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WO2011114515A1 - Manufacturing method for soft capsule using non-animal origin outer-skin, and soft capsule - Google Patents

Manufacturing method for soft capsule using non-animal origin outer-skin, and soft capsule Download PDF

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Publication number
WO2011114515A1
WO2011114515A1 PCT/JP2010/054827 JP2010054827W WO2011114515A1 WO 2011114515 A1 WO2011114515 A1 WO 2011114515A1 JP 2010054827 W JP2010054827 W JP 2010054827W WO 2011114515 A1 WO2011114515 A1 WO 2011114515A1
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WO
WIPO (PCT)
Prior art keywords
capsule
soft capsule
sheet
carrageenan
drying
Prior art date
Application number
PCT/JP2010/054827
Other languages
French (fr)
Japanese (ja)
Inventor
伸行 石川
康二 嘉島
泰規 山田
通世 赤池
Original Assignee
株式会社三協
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 株式会社三協 filed Critical 株式会社三協
Priority to JP2012505412A priority Critical patent/JP5621177B2/en
Priority to PCT/JP2010/054827 priority patent/WO2011114515A1/en
Publication of WO2011114515A1 publication Critical patent/WO2011114515A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816Wall or shell material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A61J3/071Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules
    • A61J3/074Filling capsules; Related operations
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A61J3/071Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules
    • A61J3/077Manufacturing capsule shells

Definitions

  • the present invention relates to "pharmaceuticals”, “specialized health foods”, “so-called health foods” and a method for producing soft capsules widely used in foods, particularly without using gelatin which is an animal raw material,
  • the present invention mainly relates to a method for producing a soft capsule having a skin portion using starch, which is a vegetable raw material, and the soft capsule.
  • soft capsules are mainly made of gelatin made from bones and skins of cows, pigs, etc., and are manufactured using a rotary die type automatic soft capsule manufacturing machine. Widely used.
  • BSE Bovine Spondiform Encepralopany
  • Patent Documents 1 and 2 disclose a technique for encapsulating a combination of carrageenan gum and mannan gum, which are gelling agents, without using gelatin. Further, Patent Document 3 discloses a technique regarding a capsule using ⁇ carrageenan. Furthermore, Patent Document 4 discloses a technique for capsules using ⁇ carrageenan and ⁇ carrageenan.
  • Non-Patent Document 1 states that “When ⁇ -mono or ⁇ -carrageenan is dispersed in water and heated to about 60 ° C. or higher, the carrageenan molecule dissolves in a random coil shape. As the material is cooled, a double helix is formed, which becomes a junction zone and gelation begins. " Because of such physical properties, when forming an encapsulated film using ⁇ carrageenan and ⁇ carrageenan, the encapsulated film sheet is at least 20-30 ° C. higher than when gelatin is used as the encapsulated film. Must be heated at. For this reason, the heat load on the capsule contents is large and there is a problem in quality, and the heat energy efficiency is also poor.
  • the encapsulated film sheet is heated.
  • the present inventor is advantageous in that the capsule contents can be encapsulated without applying a heat load at the same level as the conventional gelatin sheet (segment temperature: usually 35 to 50 ° C.), and the thermal energy efficiency is improved. Noticed.
  • the inventors of the present invention have made independent efforts and succeeded in developing a soft capsule having a non-animal derived skin (capsule skin) using starch, ⁇ carrageenan, metal salt, dextrin, plasticizer and water.
  • Patent Document 7 has been reached.
  • the present invention has been made in recognition of such a background. That is, the object of the present invention is to add a certain amount of a metal salt such as trisodium citrate in the production of a soft capsule having a non-animal-derived capsule shell using starch, ⁇ carrageenan, a metal salt, a plasticizer, and water.
  • the conventional rotary die type automatic soft capsule manufacturing method adopts the capsule skin sheet drying method by irradiating medium wavelength infrared rays, and the moisture content of the capsule skin sheet can be adjusted freely by enhancing the drying capacity.
  • the soft capsule manufacturing method supplies the outer sheet in a face-to-face relationship between a pair of die rolls, and joins the outer sheet by the butt action of the die rolls.
  • the outer skin part is formed by blending starch, ⁇ carrageenan, metal salt, plasticizer, and water as a constituent component composition of raw materials,
  • the amount of ⁇ carrageenan in the outer skin part is 5 to 25 parts by weight with respect to 100 parts by weight of starch in the solution stage before drying
  • the amount of the metal salt in the outer skin part is 1 to 20 parts by weight with respect to 100 parts by weight of starch in the solution stage before drying
  • the skin sheet is dried by medium-wavelength infrared rays until it is joined by a pair of die rolls, thereby forming a sheet having a substantially constant thickness, moderate viscosity, and moisture content. It consists of
  • the soft capsule manufacturing method of claim 2 is characterized in that the metal salt is trisodium citrate, and the wavelength of the medium wavelength infrared ray irradiated for drying the skin sheet is 0. .8 to 4.0 ⁇ m.
  • the soft capsule manufacturing method of claim 3 has a moisture content in a stage where the outer sheet is fed between a pair of die rolls by drying by infrared irradiation of medium wavelength, Preferably, it is dried to 30 to 40%, more preferably 32 to 38%.
  • the method for producing a soft capsule according to claim 4 is characterized in that, in addition to the requirement according to claim 1, 2, or 3, the hardness decrease with time is suppressed.
  • the manufacturing method of the soft capsule of Claim 6 WHEREIN In addition to a trisodium citrate, a sodium succinate, sodium gluconate, phosphoric acid. It is characterized by being one or a combination of two or more selected from the group consisting of disodium hydrogen, sodium dihydrogen phosphate, sodium chloride, potassium chloride, magnesium chloride, calcium chloride, and calcium lactate.
  • the soft capsule manufacturing method supplies a skin sheet oppositely between the pair of die rolls, In the method of manufacturing the soft capsule containing the contents inside the outer skin portion formed by supplying the contents to the outer skin sheet according to the joining, and supplying the contents to the outer skin sheet in accordance with the joining.
  • the temperature of the segment part for applying heat to the outer sheets is 30 to 40 ° C.
  • the soft capsule according to claim 8 is manufactured by the soft capsule manufacturing method according to claim 1, 2, 3, 4, 5, 6 or 7.
  • a metal salt such as trisodium citrate
  • ⁇ carrageenan that does not gel before
  • moderate viscosity and elastic force are obtained for ⁇ carrageenan, and soft capsule formation is achieved.
  • the inventors found that a suitable composition can be obtained, and completed a non-animal-derived capsule shell using an unprecedented vegetable material and a soft capsule having the capsule shell.
  • a new soft capsule manufacturing device that can adjust the moisture content of the capsule shell sheet freely by increasing the drying capacity by combining the rotary die type automatic soft capsule manufacturing machine with the capsule shell sheet drying device using medium wavelength infrared irradiation. Development has led to the soft capsule manufacturing method of the present invention.
  • the soft capsule production method of the present invention in the production of a soft capsule having a non-animal derived capsule shell using starch, ⁇ carrageenan, metal salt, plasticizer and water,
  • the conventional rotary die type automatic soft capsule manufacturing method adopts a capsule skin sheet drying method by mid-wavelength infrared irradiation to increase the drying capacity.
  • the outer skin part of the non-animal derived soft capsule produced by the soft capsule production method of the present invention is formed by blending a metal salt such as starch, ⁇ carrageenan, trisodium citrate, a plasticizer and water as a component composition.
  • the amount of water is preferably 90 to 200 parts by weight, more preferably 110 to 180 parts per 100 parts by weight of starch in the skin solution stage before drying (in the solution stage before drying the skin part). Part by weight, particularly preferably 120 to 170 parts by weight. If it is 90 parts by weight or less, the air dissolved in the capsule shell solution is difficult to escape, and in the defoaming process, the defoaming of the air becomes insufficient. It becomes easier to form.
  • the fluidity of the capsule shell solution is deteriorated, which hinders the increase in capsule filling speed, which is not preferable.
  • it is 200 parts by weight or more, the capsule skin sheet becomes too soft and is difficult to peel off from the casting drum.
  • the viscosity of 90 to 200 parts by weight of water based on 100 parts by weight of starch is 75% after dissolving at a concentration of 10% and a temperature of 85 to 95 ° C. for 6 hours. It is 1500-13000 (low viscosity) measured at ° C.
  • a viscosity of 60 to 90 parts by weight of water based on 100 parts by weight of starch was dissolved at a concentration of 10% at 85 to 95 ° C. for 6 hours. It is 13000-35000 (high viscosity) measured at 75 ° C. The viscosity was measured using a B-type viscometer manufactured by Tokimec Co., Ltd.
  • the metal salt used in the present invention is preferably trisodium citrate.
  • trisodium citrate sodium succinate, sodium gluconate, disodium hydrogen phosphate, sodium dihydrogen phosphate, potassium chloride, magnesium chloride
  • One type selected from the group consisting of or a combination of two or more types Among them, trisodium citrate, or a combination of trisodium citrate and sodium dihydrogen phosphate, or a combination of trisodium citrate and potassium chloride, or trisodium citrate, sodium dihydrogen phosphate and potassium chloride. Combinations are preferably used.
  • the mixing ratio of trisodium citrate is 1 to 20 parts by weight, preferably 2 to 15 parts by weight with respect to 100 parts by weight of starch in the skin solution stage before drying (in the solution stage before drying the skin part). Particularly preferred is 5 to 10 parts by weight.
  • trisodium citrate is 1 part by weight or less, it is impossible to prevent a decrease in capsule hardness over time after forming soft capsules.
  • the sodium salt is 20 parts by weight or more, the sodium salt concentration increases, which is not preferable as a soft capsule skin for health food.
  • the blending ratio of other metal salts is 100 parts by weight of starch at the outer skin solution stage before drying (at the solution stage before drying the outer skin part).
  • 1 to 5 parts by weight of sodium dihydrogen phosphate and 0.01 to 0.3 parts by weight of potassium chloride are preferably used. More preferably, sodium dihydrogen phosphate is 1.5 to 3 parts by weight and potassium chloride is 0.03 to 0.15 parts by weight. It is not preferable that sodium dihydrogen phosphate is 5 parts by weight or more because ⁇ carrageenan may be hydrolyzed.
  • the defoaming property of the capsule shell solution is achieved by a new capsule manufacturing method that allows the moisture content of the capsule shell sheet to be freely adjusted by irradiation with medium wavelength infrared rays.
  • the adhesive surface of the capsule skin sheet is evenly uniform. It can be dried to an appropriate water content, and it can improve the productivity and cost, such as prevention of capsule foam failure, increase the capsule filling speed, and the time-lapse hardness after capsule formation, which has been a problem in the prior art. Decrease can be prevented and hardness stability can be improved.
  • the use of trisodium citrate as a metal salt in combination with sodium dihydrogen phosphate and potassium chloride does not inhibit the action and effect of trisodium citrate.
  • Metal salts other than sodium can be used. Although the effect is not necessarily clear, an example is shown when sodium dihydrogen phosphate and potassium chloride are added.
  • a weakly acidic metal salt such as sodium dihydrogen phosphate is added to ⁇ carrageenan, which is an anionic polymer, so that an appropriate viscosity (adhesiveness) can be obtained without hydrolysis.
  • metal salts such as potassium chloride and potassium citrate
  • Non-Patent Document 1 states that “When ⁇ - or ⁇ -carrageenan is dispersed in water and heated to about 60 ° C. or higher, the carrageenan molecules dissolve in a random coil shape. When this solution is cooled, a double helix is formed, which becomes a junction zone and gelation begins. " Because of these physical properties, when forming an encapsulated film using ⁇ carrageenan and ⁇ carrageenan, encapsulation is performed more than when gelatin is used as the encapsulated film (segment temperature: usually 35 to 50 ° C.). The coated sheet must be heated at a temperature that is at least 20-30 ° C. higher.
  • ⁇ carrageenan has an appropriate viscosity and elasticity by adding a certain amount of metal salt to ⁇ carrageenan that does not gel, and completed a non-animal derived soft capsule. Therefore, unlike ⁇ carrageenan and ⁇ carrageenan, when forming an encapsulated film with ⁇ carrageenan, the same level as when gelatin is used (segment temperature: usually 35 to 50 ° C.) (segment temperature: 30 to 40).
  • the capsule contents can be encapsulated without applying an excessive heat load, and the heat energy efficiency is good.
  • the blending ratio of ⁇ carrageenan is 5 to 25 parts by weight, more preferably 7 to 20 parts by weight, and particularly preferably 10 to 15 parts by weight with respect to 100 parts by weight of starch at the stage of the skin solution before drying.
  • the starch that is the outer skin component of the non-animal derived soft capsule of the present invention is one type or a combination of two or more types selected from the group consisting of raw starch, HP-modified starch, acid-treated starch and pregelatinized starch.
  • the HP-modified starch which is a starch derivative is a hydroxypropyl etherified starch, and any HP-modified starch sold on the market can be used.
  • trade name TR-3 manufactured by Tokai Starch Co., Ltd. trade name Matsutani Yuri, Finex AG600 manufactured by Matsutani Chemical Industry Co., Ltd., trade name Delica KH manufactured by Nissho Chemical Co., Ltd.
  • trade name TR-3 manufactured by Tokai Starch Co., Ltd. trade name Matsutani Yuri
  • trade name Delica KH manufactured by Nissho Chemical Co., Ltd. can be applied.
  • the pregelatinized starch which is a starch derivative, is a cold water soluble starch that is gelatinized (dissolved) at room temperature.
  • a cold water soluble starch that is gelatinized (dissolved) at room temperature.
  • Tapioca Alpha-TP-2 manufactured by Sanwa Starch Co., Ltd. can be applied.
  • a starch decomposition product can be further used together with starch.
  • the starch degradation product is one or a combination of two or more selected from the group consisting of dextrin, maltodextrin, reduced dextrin, cyclodextrin, oligosaccharide, and polydextrose, and is a starch degradation product sold in the market. Any of them can be used.
  • trade names Paindex # 1 (dextrin), Paindex # 2 (maltodextrin), and H-PDX (reduced dextrin) manufactured by Matsutani Chemical Co., Ltd. can be used.
  • the blending ratio of the starch degradation product is 1 to 80 parts by weight, more preferably 5 to 50 parts by weight, and particularly preferably 10 to 30 parts by weight with respect to 100 parts by weight of starch in the outer skin solution stage before drying. .
  • the plasticizer that can be used in the present invention is glycerin, sugar alcohol, propylene glycol, polyethylene glycol, disaccharide, oligosaccharide, isomaltoligosaccharide and the like.
  • the blending ratio of the plasticizer is 20 to 250 parts by weight, more preferably 30 to 80 parts by weight, and particularly preferably 35 to 70 parts by weight with respect to 100 parts by weight of starch at the stage of the skin solution before drying.
  • a certain amount or more of trisodium citrate is added as a metal salt.
  • the conventional rotary die type automatic soft capsule manufacturing method adopts the capsule skin sheet drying method by mid-wavelength infrared irradiation to enhance the drying capacity and freely adjust the moisture content of the capsule skin sheet
  • the capsule skin sheet drying method by mid-wavelength infrared irradiation to enhance the drying capacity and freely adjust the moisture content of the capsule skin sheet
  • FIG. 1 It is the perspective view which shows the soft capsule manufacturing apparatus (filling machine) used by this invention, and explanatory drawing which shows the drying apparatus by medium wavelength infrared irradiation from the front. It is a front view which shows the manufacturing apparatus (filling machine) used by this invention. It is a perspective view which expands and shows the drying apparatus by medium wavelength infrared irradiation. It is a front view which shows a mode that a soft capsule is manufactured with a pair of die roll. It is a top view which shows a pair of die roll.
  • FIG. 4 is a front view of a filling machine showing double-sided drying in which a drying transfer path by mid-wavelength infrared irradiation is provided in four stages so that the front and back surfaces of the outer sheet can be dried (irradiated) twice each. It is a front view which shows the Example which supported the outer skin sheet
  • the best mode for carrying out the present invention includes one described in the following examples, and further includes various methods that can be improved within the technical idea.
  • the basic structure of the soft capsule 1 according to the present invention will be described, and then an example of a device for manufacturing the soft capsule 1 (device used in the present invention) will be described.
  • the production method of the soft capsule which is the method of the present invention will be explained together, and further the detailed explanation will be given while actually showing the component composition of the capsule shell.
  • the basic structure of the soft capsule 1 is, for example, as shown in FIG.
  • contents N materials for appropriate purposes such as foods, seasonings (seasoning oils), cosmetics, bathing agents, miscellaneous goods (toys, adhesives, etc.) can be used in addition to pharmaceuticals.
  • the encapsulated state includes a liquid form, a gel form, a granular body, or a state in which these are appropriately mixed, for example, a powder-containing suspension in which powder is mixed in a liquid. Is possible. In the following description, a case where the liquid content N is mainly stored will be described.
  • the outer skin part 2 can be based on animal-derived gelatin as in the past, but here, as described above, it is mainly composed of plant-derived starch, and specifically, Is formed by blending starch, ⁇ carrageenan, metal salt, plasticizer, and water. The specific composition of these components will be described later.
  • a soft capsule manufacturing apparatus 10 (hereinafter simply referred to as a filling machine 10) for manufacturing such a soft capsule 1 will be described.
  • a conventional rotary die type automatic soft capsule manufacturing machine can be diverted (followed), and as an example, as shown in FIG. 1, it is a raw material for forming a molten outer shell material (a raw material material for forming the outer skin portion 2). 2A), the contents N are encapsulated in the outer sheet S by joining the formed outer sheet S and the sheet forming part 11 formed into a sheet with an appropriate thickness while drying.
  • a capsule forming part 12 for wrapping, a content supply part 13 for feeding the contents N in accordance with the joining of the outer skin sheet S, and a capsule take-out part 14 for taking out the formed soft capsule 1 from the filling machine 10. is there.
  • the present invention is characterized in that the sheet forming unit 11 is provided with a drying device 15 using medium wavelength infrared irradiation, and the drying ability is remarkably improved as compared with the conventional manufacturing method.
  • the sheet forming part 11 is a part that solidifies and forms the raw material 2A in the form of a sheet.
  • a pair is provided on the left and right with the capsule forming part 12 in between.
  • the sheet forming unit 11 includes a spreader box 21 that discharges the melted skin raw material 2A in a substantially constant sheet state, and a casting drum 22 that cools the skin sheet S discharged from the spreader box 21.
  • the outer sheet S is formed into a sheet having an appropriate thickness while being cooled to an appropriate temperature. A method for dissolving the outer shell raw material 2A will be described later.
  • the drying device 15 is for drying the skin sheet S solidified into a sheet form from the skin raw material 2A and adjusting it to a desired moisture content.
  • the reason why the moisture content is adjusted by applying such drying to the outer sheet S is to improve the adhesiveness (bondability) between the sheets in the subsequent bonding. Furthermore, hardness stability over time after capsule formation can be prevented and hardness stability can be improved.
  • both surfaces of the outer sheet S are separately irradiated with medium wavelength infrared rays to dry the outer sheet S. Yes (this is double-sided drying).
  • the surface not directly attached to the casting drum 22 is first dried (this is referred to as front surface drying for convenience), and then the surface directly attached to the casting drum 22 is dried (this) For the sake of convenience)
  • front surface drying / back surface drying are viewed from another point of view, the surface corresponding to the outer side of the capsule in the state of the soft capsule 1 finally becomes the front surface drying, and the surface corresponding to the inner side of the capsule, that is, the contents Drying the surface in direct contact with N is the back surface drying.
  • the outer sheet S is peeled off from the casting drum 22 and separately dried while being transported by the feed roll 23, and this transport path is denoted by 24. That is, the transfer path 24 for both the front surface drying and the back surface drying is formed by inverting the front and back of the outer sheet S by the feed roll 23, and maintains a certain distance from above the sheet (front and back). Then, the medium wavelength infrared ray is irradiated. For this reason, each transfer path 24 is provided with a medium-wavelength infrared heater 25 that emits medium-wavelength infrared light, and a reflector 26 is provided below the heater with the outer sheet S sandwiched between them. Also on the side, some drying action is intended to improve thermal efficiency.
  • four (four) medium-wavelength infrared heaters 25 are installed for each of the front and back surfaces, but not all of them may be used. What is necessary is just to irradiate the outer sheet
  • seat S also receives heating by irradiation of mid-wavelength infrared rays simultaneously with drying, it tends to cause thermal deformation during drying (the heater temperature is about 900 ° C. as an example). That is, since the outer sheet S is always pulled in the feed direction (transfer direction) by the transfer, it is easily deformed so as to extend in the feed direction (longitudinal direction) by heating, and the width direction (depth direction) perpendicular thereto. ) Is easy to deform so as to shrink.
  • a support 27 such as a roller is provided below the skin sheet S in order to prevent this sag.
  • reference numerals (A and B) added to the transfer path 24, the medium wavelength infrared heater 25, and the like are those acting on the surface on which they act, that is, on the front side of the skin sheet S. “A” is applied to the back side, and “B” is added to it.
  • the surface of the outer skin sheet S (that is, the irradiation surface of the medium wavelength infrared rays) is blown along the air.
  • This blowing is performed in the same direction as the sheet feeding direction, that is, from the upstream side to the downstream side in the transport direction.
  • the outer sheet S is appropriately cooled, the air flow in the transfer path 24 is stabilized (a kind of rectifying action), and deformation such as sagging can be further prevented.
  • the air blowing body 28 provided on the upstream side is a slit nozzle type that is elongated in the width direction of the skin sheet S, and air along the sheet surface is uniformly distributed from the opening. It is formed to exhale.
  • the air suction body 29 provided on the downstream side is formed so that the opening is larger than the air blowing body 28 and can be sucked in a wide range. Further, as described above, since the temperature of the transfer path 24 and the outer sheet S tends to rise during drying, the thermometer 30 is provided below the medium wavelength infrared heater 25 (directly below the outer sheet S). It is considered that temperature management can be performed.
  • the cover 31 that can move up and down on the side surface of the drying device 15 to actively block the irradiation light from the medium wavelength infrared heater 25.
  • two slits 32 in the vertical direction are formed in the cover 31 in advance, and the apparatus frame (dryer main body 15A) is formed through the slits 32.
  • the butterfly bolt 33 is screwed together, and the cover 31 is moved up and down by fastening (screwing) / loosing (release) the butterfly bolt 33 and fixed. Further, it is preferable to provide a cover 34 as shown in FIG. 3 at a portion where the transfer path 24 is reversed, that is, a portion where the air blowing body 28 and the air suction body 29 are provided. This is because the inside of the apparatus main body 15A is partitioned from the external space (manufacturing room) to be a partitioned space.
  • the cover 34 shown in FIG. 3 is formed of a transparent material so that the inside can be seen from the outside during manufacture, and is formed so that it can be horizontally rotated in a folded state so that it can be folded compactly. .
  • the portion described above becomes the sheet forming portion 11, and thereafter, the capsule forming portion 12 is provided on the side to which the outer sheet S is supplied, and the feed roll is relayed between the two forming portions. 37 is provided. That is, the outer sheet S having an appropriate moisture content by the sheet forming unit 11 (drying device 15) is sent to the capsule forming unit 12 while passing between the plurality of feed rolls 37 in a zigzag manner.
  • this includes a pair of left and right die rolls 38 as main members, and one of these die rolls 38 is fixed, and the other is configured to be able to approach and separate from the fixed die roll 38. Is done.
  • Each die roll 38 is provided with a molding recess 39 having an appropriate shape on its surface and a molding projection 40 on its peripheral edge.
  • a soft capsule 1 having a substantially spindle shape or a substantially spheroid shape is provided.
  • the molding recess 39 can be formed in an oval shape with a recessed central portion.
  • the shrinkage of the soft capsule 1 after the capsule molding becomes more intense than in the case where gelatin is the major component. Is formed. Then, the pair of die rolls 38 rotate in a state where the molding projections 40 substantially match each other, so that the outer sheet S supplied in a state of being entangled between the die rolls 38 is brought into contact with each other in a timely manner. Suture (joining) is performed.
  • the pocket portion P for receiving the content N can be naturally formed in the outer sheet S with the supply (delivery) of the content N without taking a particularly positive measure.
  • the outer sheet S sent between the die rolls 38 is actively sucked by suction from the suction holes 41 formed in the bottom of each molding recess 39, and the inclusion liquid N is received.
  • the pocket portion P is curved in advance.
  • the pocket portion P can be formed by embossing the outer sheet S before the contents N are supplied. is there.
  • the present applicant has already applied for a patent and has obtained a patent (Japanese Patent Laid-Open No. 10-2111257 (Patent No. 3211148)). And gelatin manufacturing method and manufacturing apparatus thereof).
  • the content supply unit 13 will be described. This is to supply the contents N such as liquid to the skin sheet S before the sewing around the capsule is completed, more specifically, in accordance with the joining of the skin sheet S.
  • a projecting segment 44 formed so as to sufficiently enter between the die rolls 38 as a main member.
  • the content supply unit 13 is provided with a stock solution hopper 45 in the upper portion, and stores the stock solution (contents N) therein.
  • a pump unit 46 is provided, which is appropriately formed by combining a plurality of plungers, etc., and injecting the content N from a plurality of paths at a predetermined timing, pressure, etc. It is discharged from the segment 44 to the outer sheet S via the delivery pipe 47.
  • the capsule take-out part 14 for taking out the soft capsule 1 after molding will be described below the die roll 38.
  • the soft capsule 1 after molding often fits in the molding concave portion 39 of the die roll 38, and therefore, the scraping brush 50 provided so as to come into contact with the die roll 38.
  • the soft capsule 1 thus scraped off is conveyed to the front surface of the filling machine 10 by a pair of forward conveyors 51 provided along the rotational axis direction of the die roll 38 (see FIG. 1).
  • a blank sheet S ′ after the soft capsule 1 has been punched is sandwiched between both sides and fed downward as it is between a pair of forward conveyors 51. Is adjustable).
  • the free roller 52 is configured so that the soft capsule 1 remaining on the blank sheet S ′ can be discharged onto one of the forward conveyors 51 in consideration of the fact that the soft capsule 1 may remain on the blank sheet S ′. It is preferable that Moreover, after the soft capsule 1 is conveyed to the front surface of the filling machine 10 by the advance conveyor 51, the soft capsule 1 is further transferred to another conveyor 53 and conveyed to the next drying step.
  • the two sheet sheets S are fed between the pair of die rolls 38, and at a predetermined timing from the segment 44 positioned above them.
  • Content N is supplied. That is, the two outer sheets S supplied to the die roll 38 are individually stitched around the capsule (around the molding recess 39) one by one by the abutting action of a large number of molding protrusions 40 provided on the peripheral surface. go. At this time, since the outer sheet S is subjected to a pressure of, for example, about 150 to 200 kg by the molding protrusion 40, the stitched portion is effectively glued and stitched.
  • the soft capsule 1 in which the surrounding stitches have been completed is dried after being taken out from the molding recess 39, the blank sheet S ′, etc. as described above.
  • a tumbler dryer rotary drum dryer
  • the soft capsule manufacturing apparatus 10 (filling machine 10) used in the present invention has the basic structure as described above.
  • the embodiment of manufacturing the soft capsule 1 by the filling machine 10 will be described together with the present invention.
  • a method for producing a soft capsule which is a method, will be described.
  • the aspect which mixes and supplies the outer skin component component (outer raw material 2A) of the soft capsule 1 to the filling machine 10 will be described.
  • a method using a bucket type heating and melting pot will be described.
  • the heating and melting step of melting the outer shell raw material 2A is performed by placing starch, ⁇ carrageenan, metal salt, plasticizer, and water in a heating and melting pot at 0.05 to 0.3 MPa. Under a pressure of (usually 0.2 MPa), the mixture is heated and dissolved at a temperature of 90 to 120 ° C. (usually 110 ° C.) for a time of 60 to 100 minutes (usually 80 minutes) while stirring at a rotational speed of 50 to 70 rpm.
  • the defoaming process in the first stage is performed with a defoaming pressure of ⁇ 400 to ⁇ 600 mmHg (usually ⁇ 500 mmHg), a defoaming pressure expressed as a degassing temperature of 100 to 110 ° C. (usually 105 ° C.), and an atmospheric pressure of 0 (zero).
  • the foaming time is 15 to 70 minutes (usually 30 minutes). At this time, the first 5 to 15 minutes (usually 10 minutes) is rotated with a stirrer of 10 rpm, and then the deaeration is performed with the stirrer stopped.
  • the defoaming step in the second stage is performed by raising the defoaming temperature to 110 to 130 ° C. (usually 120 ° C.), and defoaming pressure ⁇ 400 to ⁇ 600 mmHg (usually ⁇ 500 mmHg) in the gauge pressure notation where the atmospheric pressure is 0 (zero). Defoaming is performed with a defoaming time of 10 to 20 minutes (usually 15 minutes).
  • the vacuum melting pot used in the heating and melting step and the defoaming step is not particularly limited.
  • a trade name: high viscosity vacuum stirrer manufactured by Shoyu Machinery Co., Ltd., model: SY-HMD-200
  • a vacuum pump used for a defoaming process For example, a water seal type
  • the obtained outer raw material 2A in a solution state is transferred to a pressure-resistant subdivision tank and heated and stored at 60 to 90 ° C. (usually 75 ° C.) for about 12 to 24 hours.
  • the skin raw material 2A is extruded from the subdivision tank under a pressure of 0.01 to 0.1 MPa (usually 0.05 MPa), It is stored in the spreader box 21 of the filling machine 10. Further, by adjusting the gap between the casting drum 22 and the spreader box 21, the outer sheet S having a constant thickness is created. The temperature of the casting drum 22 at this time is maintained at a constant temperature of 17 to 22 ° C. (normal temperature is 20 ° C.) by air cooling or water cooling.
  • the filling chamber humidity (manufacturing chamber humidity) at this time is maintained at a constant humidity of 20 to 26% RH (usually 23% RH), and the filling chamber temperature (manufacturing chamber temperature) is 22 to 27 ° C. (usually 25 ° C.). C)) is preferably maintained at a constant temperature.
  • the outer sheet S discharged from the spreader box 21 is placed on the casting drum 22 and rotated about 3 ⁇ 4 yen (about 270 degrees), and then peeled off from the casting drum 22 and formed on the upper side thereof. 24, where it undergoes both-side drying by medium wavelength infrared irradiation. That is, the outer sheet S sent out from the casting drum 22 is first dried by the medium wavelength infrared heater 25A while passing through the transfer path 24A, and then reversed by the feed roll 23. This time, the back surface (inside the capsule) is dried by the medium wavelength infrared heater 25B, whereby both sides of the outer sheet S are dried.
  • the moisture content of the outer sheet S is preferably 30 to 40%, more preferably 32 to 38% by the medium wavelength infrared energy emitted from the medium wavelength infrared heater 25.
  • it is dried to 33 to 37% (moisture content is measured by Shimadzu Corporation trade name: MOISTURE BALANCE, model: MOC-120H). This is because when the moisture content of the skin sheet S is less than 30% or more than 40%, the adhesion between the skin sheets S and the hardness stability after the capsule formation tend to decrease, which is not preferable. .
  • the wavelength of the medium wavelength infrared ray emitted from the medium wavelength infrared heater 25 is preferably 0.8 to 4.0 ⁇ m, more preferably 1.3 to 3.0 ⁇ m, and particularly preferably 2.5 to 2.7 ⁇ m.
  • the medium wavelength infrared heater 25 any medium wavelength infrared ray can be used as long as the wavelength of the emitted medium wavelength infrared ray satisfies the above conditions and is sold on the market.
  • trade name: medium wavelength infrared heater manufactured by Heraeus Co., Ltd., model number: MBS 1600/250 can be applied.
  • the reflection plates 26A and 26B are provided below the medium wavelength infrared heaters 25A and 25B, the outer skin sheet S passing between the medium wavelength infrared heater 25 and the reflection plate 26 passes through. As a result, the thermal efficiency is improved. In addition, the skin sheet S is easily deformed by heat from the heater during drying, but in this embodiment, the support 27 such as a roller prevents sagging due to heat. Further, since air is flowed on the irradiation surface of the outer sheet S in the same direction as the sheet transfer direction, an excessive increase in the sheet temperature is prevented.
  • the skin sheet S thus dried and adjusted to an appropriate moisture content is then fed into the capsule forming part 12 (between the die rolls 38) via the feed roll 37 and joined there. Further, along with this, the contents N are supplied to the skin sheet S at the joining portion, and the soft capsule 1 containing the contents N is formed in the skin part 2. As described above, the soft capsule 1 formed in this manner is fitted into the molding recess 39 of the die roll 38 or remains in the blank sheet S ′, and is thus taken out and dried.
  • the capsule filling speed is usually represented by the number of revolutions of the die roll 38 (die) (rpm: revolution per minute).
  • rpm revolution per minute
  • the capsule filling speed is usually represented by the number of revolutions of the die roll 38 (die) (rpm: revolution per minute).
  • the present invention has the above-described embodiment as one basic technical idea, but the following modifications can be considered. That is, in the embodiment described above, the transfer paths 24A and 24B acting on the front and back surfaces of the outer sheet S are separately formed, and the medium wavelength infrared heaters 25A and 25B are irradiated with the medium wavelength infrared rays in these. The both sides of the skin sheet S were dried. However, when the skin sheet S can be sufficiently dried to the inside of the sheet only by irradiation from one side, it may be dried by either one of the transfer paths 24A and 24B.
  • the sheet can be uniformly dried by such single-sided drying, it is not necessary to reversely form the transfer path 24A, and after the outer sheet S is peeled from the casting drum 22, the joining portion (a pair of die rolls) It is also possible to form a transfer path 24 for drying (irradiation) until it is fed to (between 38) and irradiate it with medium-wavelength infrared rays for drying.
  • drying can be performed by single-sided drying, it is possible to dry the outer sheet S without providing the transfer path 24 separately.
  • a dry form for example, as shown in FIG. 6, in the vicinity of the casting drum 22 (here, a position rotated about 1/4 circle (about 90 degrees) after being discharged from the spreader box 21), a medium wavelength is used.
  • An infrared heater 25 is provided and is dried at a stage where the outer sheet S is placed on the casting drum 22 (a stage before being peeled from the casting drum 22).
  • the filling machine 10 shown in FIG. 6 is suitable for manufacturing a soft capsule 1 mainly composed of conventional gelatin. If gelatin is the main component, it may be possible to sufficiently dry even if it does not have a drying capability as high as that of the medium wavelength infrared ray. This is because the conventional dry form, that is, the form in which only one side of the capsule skin sheet S (the outside of the capsule) is dried with only the casting drum 22 (water content is 19 to 23%) can be obtained. It may seem that the single-sided drying on the casting drum 22 is similar to a conventional rotary die type automatic soft capsule manufacturing machine, but in the present invention, it is irradiation with medium-wavelength infrared rays and not mere air blowing.
  • the non-animal derived skin sheet S containing starch, ⁇ carrageenan, metal salt, plasticizer, and water can be sufficiently dried, and the adhesiveness of the skin sheet S can be enhanced. Furthermore, hardness stability over time after capsule formation can be prevented and hardness stability can be improved. It is also possible to freely dry both sides of the outer sheet S.
  • the medium-wavelength infrared heater 25 is provided in three or more stages as described above, it is not always necessary to operate (operate) the medium-wavelength infrared heater 25 at all stages for drying. Naturally, it is possible to allow only necessary portions to act in accordance with the composition component of the outer shell raw material 2A and the desired moisture content value to be dried.
  • the roller is applied as the support 27 that receives the outer sheet S irradiated with the medium wavelength infrared rays from below.
  • the support 27 is not necessarily limited to the roller.
  • a conveyor or the like can be applied. The conveyor here is naturally driven at the same transfer speed as the outer sheet S.
  • the present invention will be described in more detail with reference to more detailed examples.
  • the present invention is not limited to these examples, and vegetable oils, animal oils, combinations of vegetable oils and animal oils, and various fats and oils are also described. It can be applied to all those that can be encapsulated with a mixture of various fats and oils such as suspension oils containing animal and plant extracts and extract powders.
  • the evaluation items and the evaluation methods used in the comparative examples and examples will be described.
  • the first 10 minutes is rotated with a stirrer of 10 rpm, and then the deaeration is performed with the stirrer stopped.
  • the defoaming temperature is raised to 120 ° C., and the defoaming pressure is degassed in a gauge pressure notation of ⁇ 500 mmHg with a defoaming time of 15 minutes.
  • the soft capsule shell solution obtained after defoaming was transferred to a small tank and stored at 75 ° C. for about 15 hours for use.
  • a conventional rotary die type automatic soft capsule manufacturing machine was used as a filling machine.
  • the obtained soft capsule skin solution was discharged from a spreader box and spread on cooling drums on both sides of the filling machine to form a sheet (outer sheet).
  • the outer skin sheet was guided to a filling machine, and immediately after the contents (mixture of 70% by weight of MCT and 30% by weight of lecithin) were filled, a soft capsule was obtained by pressure bonding with a die (die roll).
  • Die roll ⁇ Filling conditions> Casting drum temperature: 20 ° C Segment temperature: 30 ° C Die roll rotation speed: 1.5 rpm in Comparative Example 1 and Comparative Example 2 In Comparative Example 3, 3.0 rpm Filling room humidity: 24% RH Filling chamber temperature: 26 ° C
  • the first 10 minutes is rotated with a stirrer of 10 rpm, and then the deaeration is performed with the stirrer stopped.
  • the defoaming temperature is raised to 120 ° C., and the defoaming pressure is degassed in a gauge pressure notation of ⁇ 500 mmHg with a defoaming time of 15 minutes.
  • the soft capsule shell solution obtained after defoaming was transferred to a small tank and stored at 75 ° C. for about 15 hours for use.
  • a soft capsule manufacturing machine provided with a capsule skin sheet drying apparatus by infrared irradiation with medium wavelength, which is an apparatus developed by the present inventors, was used.
  • the obtained soft capsule skin solution was discharged from a spreader box and spread on cooling drums 22 on both sides of the filling machine 10 to form a sheet (outer sheet S). While drying the skin sheet S to a moisture content of 32% with a medium wavelength infrared heater, the skin sheet S is guided to the filling machine 10 and the contents (mixture of 70% by weight of MCT and 30% by weight of lecithin) are obtained. Immediately after filling, the soft capsule 1 was obtained by pressure bonding with a die (die roll 26).
  • Example 1 the capsule shell component containing trisodium citrate as a metal salt was placed in a heated dissolution kettle and stirred at a pressure of 0.2 MPa while stirring at a rotating speed of 50 to 70 rpm. Dissolve by heating at 110 ° C. for 80 minutes.
  • a two-stage defoaming process is performed.
  • the defoaming step in the first stage is performed at a defoaming temperature of 105 ° C. and a defoaming pressure of ⁇ 500 mmHg and a defoaming time of 30 minutes in terms of gauge pressure with the atmospheric pressure being 0 (zero).
  • the first 10 minutes is rotated with a stirrer of 10 rpm, and then the deaeration is performed with the stirrer stopped.
  • the defoaming temperature is raised to 120 ° C., and the defoaming pressure is degassed in a gauge pressure notation of ⁇ 500 mmHg with a defoaming time of 15 minutes.
  • the soft capsule shell solution obtained after defoaming was transferred to a small tank and stored at 75 ° C. for about 15 hours for use.
  • the filling machine 10 a soft capsule manufacturing machine provided with a capsule skin sheet drying apparatus using medium wavelength infrared irradiation, which is an apparatus developed by the present inventors, was used.
  • the obtained soft capsule outer skin solution (outer raw material 2A) was spread on the cooling drums 22 on both sides of the filling machine 10 to form a sheet (outer sheet S). While drying the skin sheet S to 32% by the medium wavelength infrared heater 25, the skin sheet S is guided to the filling machine 10 and the contents (mixture of 70% by weight of MCT and 30% by weight of lecithin). Immediately after filling, a soft capsule 1 was obtained by pressure bonding with a mold (die roll 38).
  • Comparative Example 1 Comparative Example 2, Comparative Example 3 Evaluation Results
  • Comparative Example 2 when the water content of the capsule shell solution was 80 parts by weight with a conventional rotary die type automatic soft capsule manufacturing machine (die roll rotation speed: 1.5 rpm), it was dissolved in the capsule shell solution. It was difficult for air to escape and the capsule foam defect rate increased.
  • Comparative Example 2 when the amount of water in the capsule shell solution was 150 parts by weight with a conventional rotary die type automatic soft capsule manufacturing machine (die roll rotation speed: 1.5 rpm), it was removed from Comparative Example 1.
  • Comparative Example 4 In Comparative Example 4 in which trisodium citrate was not blended but sodium dihydrogen phosphate and potassium chloride were blended, a soft capsule provided with a capsule skin sheet drying device by mid-wavelength infrared irradiation, which was developed by the present inventors When using the manufacturing equipment, compared with Comparative Examples 1, 2, and 3, even if the die roll speed is doubled from 1.5 to 3.0 rpm, the bubble defect rate is low, the adhesion is very good, and the liquid capsule does not leak Can be manufactured. However, a decrease in hardness over time after capsule formation has occurred, and the problem of hardness stability remains unsolved.
  • Example 1 Example 2, Example 3 in which trisodium citrate was blended, when a soft capsule manufacturing apparatus provided with a capsule skin sheet drying apparatus by mid-wavelength infrared irradiation, which was developed by the present inventors, was used. Compared with Comparative Examples 1, 2, and 3, even when the die roll speed is doubled from 1.5 to 3.0 rpm, a soft capsule that has a low bubble defect rate, very good adhesion, and does not leak can be manufactured. It was. Further, even after using a soft capsule manufacturing apparatus equipped with a capsule skin sheet drying apparatus using medium wavelength infrared irradiation, which was an apparatus developed by the present inventors as in Comparative Example 4, time elapsed after capsule formation. No decrease in hardness occurred in Examples 1, 2, and 3, and the hardness stability could be improved.
  • the difficulty when the starch is the main ingredient as the outer skin raw material 2A (difficulty compared with the case where the gelatin is the main ingredient) will be described.
  • starch is the main component
  • a long transfer path 24 is simply formed to dry for a long time. It is not enough to just do it.
  • the drying is accompanied by deformation due to heat, and in particular, when the transfer path 24 is formed longer, the corresponding amount (the longer it is formed), the tension (pulling force) applied to the outer sheet S for transfer. This is because the soft capsule 1 in a completed state is easily deformed.
  • the size of the molding recess 39 of the die roll 38 is substantially the same as that of the completed soft capsule 1, but (when gelatin is the main component, the completed soft capsule 1 is In the soft capsule 1 in which starch is the main component, the soft capsule 1 is formed in substantially the same size), and contracts more greatly in the rotational direction of the die roll 38 (feeding direction of the outer sheet S) than the actual size of the molding recess 39 (for example, FIG. As shown by the two-dot chain line in the enlarged view, it shrinks by about 10 to 30%), making it much more difficult to manufacture compared to the case where gelatin is the main component.
  • the present invention can be used in the fields of “pharmaceuticals”, “special health foods”, “so-called health foods” and foods, as well as in industrial fields such as those containing industrial preparations depending on the selection of contents. it can.

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Abstract

Disclosed is a novel manufacturing method, which is a manufacturing procedure wherein a capsule is formed by combining starch, λ-carrageenan, metallic salt, a plasticiser, and water as the structural component composition for the raw materials for the outer-skin part of the capsule, and which has enhanced the drying ability of conventional rotary-die type soft capsule manufacturing methods, enabling the water content of a capsule outer-skin sheet to be freely adjusted, and which also has improved the previously problematic post-formation hardness-stability of the capsule. In the disclosed soft capsule manufacturing method a capsule is formed by combining starch, λ-carrageenan, metallic salt, a plasticiser, and water as the structural component composition for the raw materials for the outer-skin part of the capsule. In addition to being a novel method wherein trisodium citrate is mixed as the metallic salt, the method is characterised by the introduction to conventional rotary-die type automatic soft capsule manufacturing methods of a drying procedure for the capsule outer-skin sheet using medium wavelength infra-red radiation, thus enhancing drying ability and enabling the water content of the capsule outer-skin sheet to be freely adjusted.

Description

非動物由来外皮を有したソフトカプセルの製造方法並びにそのソフトカプセルMethod for producing soft capsule having non-animal derived skin and soft capsule
 本発明は、「医薬品」、「特定保健用食品」、「いわゆる健康食品」及び食品に広く汎用されているソフトカプセルの製造手法に関するものであり、特に動物性原料であるゼラチンを使用せずに、主に植物性原料である澱粉を用いた外皮部を有するソフトカプセルの製造方法並びにそのソフトカプセルに係るものである。  The present invention relates to "pharmaceuticals", "specialized health foods", "so-called health foods" and a method for producing soft capsules widely used in foods, particularly without using gelatin which is an animal raw material, The present invention mainly relates to a method for producing a soft capsule having a skin portion using starch, which is a vegetable raw material, and the soft capsule. *
 従来からソフトカプセルは、牛、豚などの骨や皮などより製されているゼラチンを主成分とし、ロータリーダイ式自動ソフトカプセル製造機を用いて製造することで「医薬品」や「いわゆる健康食品」分野で広く使用されている。
 しかしながら、近年、BSE(Bovine Spondiform Encepralopany;牛海綿状脳症)の発生が報告されて以来、動物性のゼラチンを使用せずに非動物由来の素材を用いたソフトカプセル外皮の開発に注目が集まっている。
Traditionally, soft capsules are mainly made of gelatin made from bones and skins of cows, pigs, etc., and are manufactured using a rotary die type automatic soft capsule manufacturing machine. Widely used.
However, in recent years, since the occurrence of BSE (Bovine Spondiform Encepralopany) has been reported, attention has been focused on the development of soft capsule shells using non-animal derived materials without using animal gelatin. .
 このような状況のもと特許文献1、2では、ゲル化剤であるカラゲナンガムとマンナンガムの組み合わせでゼラチンを使用することなくカプセル化する技術が公開されている。また、特許文献3においてはκカラギーナンを用いたカプセルについての技術も公開されている。さらに、特許文献4においてはιカラギーナン及びκカラギーナンを用いたカプセルについての技術も公開されている。 Under such circumstances, Patent Documents 1 and 2 disclose a technique for encapsulating a combination of carrageenan gum and mannan gum, which are gelling agents, without using gelatin. Further, Patent Document 3 discloses a technique regarding a capsule using κ carrageenan. Furthermore, Patent Document 4 discloses a technique for capsules using ι carrageenan and κ carrageenan.
 κカラギーナン及びιカラギーナンの性質として、非特許文献1には、「κ一またはι-カラギーナンを水に分散し、約60℃以上に加熱すると、カラギーナンの分子はランダムコイル状に溶解する。この溶液を冷却していくとダブルヘリックスが形成され、これがジャンクションゾーンとなってゲル化が始まる。」と記載されている。このような物性をもつため、ιカラギーナン及びκカラギーナンを用いてカプセル化皮膜を形成する際には、カプセル化皮膜としてゼラチンを用いる際よりも、カプセル化皮膜シートを少なくとも20~30℃分高い温度で加熱しなければならない。そのため、カプセル内容物への熱負荷が大きく品質上問題があり、また熱エネルギー効率も悪かった。 Regarding the properties of κ carrageenan and ι carrageenan, Non-Patent Document 1 states that “When κ-mono or ι-carrageenan is dispersed in water and heated to about 60 ° C. or higher, the carrageenan molecule dissolves in a random coil shape. As the material is cooled, a double helix is formed, which becomes a junction zone and gelation begins. " Because of such physical properties, when forming an encapsulated film using ι carrageenan and κ carrageenan, the encapsulated film sheet is at least 20-30 ° C. higher than when gelatin is used as the encapsulated film. Must be heated at. For this reason, the heat load on the capsule contents is large and there is a problem in quality, and the heat energy efficiency is also poor.
 このような状況のもと、κカラギーナン及びιカラギーナンとは異なりゲル化しないλカラギーナン(非特許文献2、3参照)を用いてカプセル化皮膜を形成することができれば、カプセル化皮膜シートの加熱を従来のゼラチンシートと同レベル(セグメント部温度:通常35~50℃)でカプセル内容物に熱負荷をかけることなくカプセル化でき、熱エネルギー効率が良くなるなどの利点があることに、本発明者らは気付いた。そして、本発明者らは独自に鋭意努力して、澱粉、λカラギーナン、金属塩、デキストリン、可塑剤及び水を用いた非動物由来の外皮部(カプセル外皮)を有したソフトカプセルの開発に成功し、まず先に特許出願(特許文献7)に及んでいる。 Under these circumstances, if the encapsulated film can be formed using λ carrageenan that does not gel unlike κ carrageenan and ι carrageenan (see Non-Patent Documents 2 and 3), the encapsulated film sheet is heated. The present inventor is advantageous in that the capsule contents can be encapsulated without applying a heat load at the same level as the conventional gelatin sheet (segment temperature: usually 35 to 50 ° C.), and the thermal energy efficiency is improved. Noticed. The inventors of the present invention have made independent efforts and succeeded in developing a soft capsule having a non-animal derived skin (capsule skin) using starch, λ carrageenan, metal salt, dextrin, plasticizer and water. First, the patent application (Patent Document 7) has been reached.
 しかし、澱粉、λカラギーナン、金属塩、可塑剤及び水を用いた非動物由来カプセル外皮を有したソフトカプセルを、従来のロータリーダイ式自動ソフトカプセル製造機(例えば特許文献5~6)で製造する方法では、非動物由来カプセル外皮シート製造工程における乾燥能力が不十分なため、カプセル外皮溶液の水分配合量を少なくして乾燥負荷を減らさなければならない状況であった。
 だが、そのように水分配合量を少なくすると、カプセル外皮溶液中に溶け込んだエアが脱泡工程で抜けにくくなり、カプセル外皮シートに目視で確認可能な気泡が残ってしまう泡不良のカプセルが形成される課題を抱えていた。
 また、従来のロータリーダイ式自動ソフトカプセル製造機を用い、水分配合量を少なくして乾燥負荷を減らしたとしても、その高粘度なカプセル外皮溶液の供給は、時間をかけて行う必要があり、ソフトカプセルの充填速度を上げると、カプセル外皮シート製造工程における乾燥能力が追随できないだけでなく、カプセル外皮溶液の供給が間に合わず、生産性向上の妨げにもなっていた。さらに、カプセル形成後の経時的な硬度低下が、品質上大きな問題になっていた。
However, in a method for producing a soft capsule having a non-animal-derived capsule shell using starch, λ carrageenan, a metal salt, a plasticizer, and water with a conventional rotary die type automatic soft capsule production machine (for example, Patent Documents 5 to 6). Since the drying ability in the non-animal-derived capsule skin sheet manufacturing process is insufficient, the moisture load of the capsule skin solution must be reduced to reduce the drying load.
However, if the water content is reduced in this way, the air dissolved in the capsule shell solution becomes difficult to escape in the defoaming process, and a bubble-poor capsule is formed in which bubbles that can be visually confirmed remain on the capsule shell sheet. I had a problem.
Even if a conventional rotary die type automatic soft capsule manufacturing machine is used to reduce the drying load by reducing the amount of water blended, it is necessary to supply the high-viscosity capsule shell solution over time. When the filling speed of the capsule shell is increased, not only the drying ability in the capsule shell sheet manufacturing process cannot be followed, but also the supply of the capsule shell solution is not in time, which hinders improvement in productivity. Furthermore, a decrease in hardness over time after capsule formation has been a major problem in quality.
米国特許第5342626号US Pat. No. 5,342,626 特開平6-329833号JP-A-6-329833 米国特許第6214376号U.S. Pat. No. 6,214,376 特表2003-504326Special table 2003-504326 特公平5-88143JP 5-88143 特開2003-40768JP2003-40768 特開2008-237572JP2008-237572
本発明は、このような背景を認識してなされたものである。すなわち、本発明の課題は、澱粉、λカラギーナン、金属塩、可塑剤、及び水を用いた非動物由来カプセル外皮を有するソフトカプセルの製造において、一定量のクエン酸三ナトリウムなどの金属塩を加えるという新たな製造手法に加え、さらに、従来のロータリーダイ式自動ソフトカプセル製造手法に、中波長赤外線照射によるカプセル外皮シート乾燥手法を採り入れ、乾燥能力を増強してカプセル外皮シートの水分含量を自在に調整可能とした新たなカプセル製造手法を開発することにより、
 カプセル外皮溶液の脱泡性、流動性を向上させるために水分配合量を多く(澱粉100重量部に対し、90~200重量部)して低粘度でカプセル外皮溶液を仕込んでも、カプセル外皮シートの接着面を均一にムラなく適度な水分含量に乾燥でき、カプセル泡不良の防止、カプセル充填速度アップなど生産性、コスト面の向上を実現し、さらには、従来技術で問題になっていた、カプセル形成後の経時的な硬度低下を防止して硬度安定性を向上させた新たな製造方法並びに、そのソフトカプセルを提供することである。
The present invention has been made in recognition of such a background. That is, the object of the present invention is to add a certain amount of a metal salt such as trisodium citrate in the production of a soft capsule having a non-animal-derived capsule shell using starch, λ carrageenan, a metal salt, a plasticizer, and water. In addition to the new manufacturing method, the conventional rotary die type automatic soft capsule manufacturing method adopts the capsule skin sheet drying method by irradiating medium wavelength infrared rays, and the moisture content of the capsule skin sheet can be adjusted freely by enhancing the drying capacity. By developing a new capsule manufacturing method,
In order to improve the defoaming property and fluidity of the capsule shell solution, even if the amount of water is increased (90 to 200 parts by weight with respect to 100 parts by weight of starch) and the capsule shell solution is charged with a low viscosity, Capable of drying the adhesive surface uniformly and uniformly to an appropriate water content, preventing capsule foam failure, increasing capsule filling speed, and improving productivity and cost. It is to provide a new production method in which hardness stability is improved by preventing a decrease in hardness over time after formation, and a soft capsule thereof.
 まず請求項1記載のソフトカプセルの製造方法は、一対のダイロール間に外皮シートを対向的に拝み合わせ状態に供給し、ダイロールの突合わせ作用によって外皮シートの接合を図るとともに、接合に合わせて内容物を外皮シートに供給し、外皮シートから成る外皮部の内側に内容物を収容したソフトカプセルを製造する方法において、
 前記外皮部は、原料の構成成分組成として澱粉、λカラギーナン、金属塩、可塑剤、及び水を配合して形成され、
 前記外皮部のλカラギーナンの配合量が、乾燥前の溶液段階で澱粉100重量部に対して5~25重量部であり、
 前記外皮部の金属塩の配合量が、乾燥前の溶液段階で澱粉100重量部に対して1~20重量部であり、
 前記外皮シートは、一対のダイロールによる接合を受けるまでの間に、中波長赤外線による乾燥を受け、これによりほぼ一定の厚さ、適度の粘性、水分含量を有するシート状に形成されることを特徴として成るものである。
First, the soft capsule manufacturing method according to claim 1 supplies the outer sheet in a face-to-face relationship between a pair of die rolls, and joins the outer sheet by the butt action of the die rolls. In the method of manufacturing the soft capsule containing the contents inside the outer skin part consisting of the outer skin sheet,
The outer skin part is formed by blending starch, λ carrageenan, metal salt, plasticizer, and water as a constituent component composition of raw materials,
The amount of λ carrageenan in the outer skin part is 5 to 25 parts by weight with respect to 100 parts by weight of starch in the solution stage before drying,
The amount of the metal salt in the outer skin part is 1 to 20 parts by weight with respect to 100 parts by weight of starch in the solution stage before drying,
The skin sheet is dried by medium-wavelength infrared rays until it is joined by a pair of die rolls, thereby forming a sheet having a substantially constant thickness, moderate viscosity, and moisture content. It consists of
 また請求項2のソフトカプセルの製造方法は、前記請求項1記載の要件に加え、前記金属塩がクエン酸三ナトリウムであり、前記外皮シートを乾燥させるために照射する中波長赤外線の波長は、0.8~4.0μmであることを特徴として成るものである。 In addition to the requirement of claim 1, the soft capsule manufacturing method of claim 2 is characterized in that the metal salt is trisodium citrate, and the wavelength of the medium wavelength infrared ray irradiated for drying the skin sheet is 0. .8 to 4.0 μm.
 また請求項3のソフトカプセルの製造方法は、前記請求項1または2記載の要件に加え、前記外皮シートは、中波長赤外線照射による乾燥によって、一対のダイロール間に送り込まれる段階での水分含量が、好ましくは30~40%、より好ましくは32~38%に乾燥されることを特徴として成るものである。 In addition to the requirements of claim 1 or 2, the soft capsule manufacturing method of claim 3 has a moisture content in a stage where the outer sheet is fed between a pair of die rolls by drying by infrared irradiation of medium wavelength, Preferably, it is dried to 30 to 40%, more preferably 32 to 38%.
 また請求項4のソフトカプセルの製造方法は、前記請求項1、2または3記載の要件に加え、経時的な硬度低下を抑制したことを特徴として成るものである。 Further, the method for producing a soft capsule according to claim 4 is characterized in that, in addition to the requirement according to claim 1, 2, or 3, the hardness decrease with time is suppressed.
 また請求項5のソフトカプセルの製造方法は、前記請求項1、2、3または4の要件に加え、前記λカラギーナンに対する比率が、λカラギーナン:κカラギーナン:ιカラギーナン=1:0.1:0.1~1:4:4のκカラギーナンとιカラギーナンを更に含有することを特徴として成るものである。 According to a fifth aspect of the present invention, in addition to the requirements of the first, second, third, or fourth aspect, the ratio to the λ carrageenan is λ carrageenan: κ carrageenan: ι carrageenan = 1: 0.1: 0. It further comprises 1 to 1: 4: 4 κ carrageenan and ι carrageenan.
 また請求項6のソフトカプセルの製造方法は、前記請求項1、2、3、4または5の要件に加え、前記金属塩が、クエン酸三ナトリウムの他、コハク酸ナトリウム、グルコン酸ナトリウム、リン酸水素二ナトリウム、リン酸二水素ナトリウム、塩化ナトリウム、塩化カリウム、塩化マグネシウム、塩化カルシウム、乳酸カルシウムからなる群から選ばれる1種類又は2種類以上の組み合わせであることを特徴として成るものである。 Moreover, in addition to the requirements of the said claim 1, 2, 3, 4 or 5, the manufacturing method of the soft capsule of Claim 6 WHEREIN: In addition to a trisodium citrate, a sodium succinate, sodium gluconate, phosphoric acid. It is characterized by being one or a combination of two or more selected from the group consisting of disodium hydrogen, sodium dihydrogen phosphate, sodium chloride, potassium chloride, magnesium chloride, calcium chloride, and calcium lactate.
 また請求項7のソフトカプセルの製造方法は、前記請求項1、2、3、4、5または6の要件に加え、前記一対のダイロール間に外皮シートを対向的に拝み合わせ状態に供給し、ダイロールの突合わせ作用によって外皮シートの接合を図るとともに、接合に合わせて内容物を外皮シートに供給し、外皮シートから成る外皮部の内側に内容物を収容したソフトカプセルを製造する方法において、前記ダイロールの突合わせ作用によって外皮シートの接合を図る際に、外皮シートに熱をかけるためのセグメント部の温度が30~40℃であることを特徴として成るものである。 In addition to the requirements of the first, second, third, fourth, fifth, or sixth aspect, the soft capsule manufacturing method according to the seventh aspect supplies a skin sheet oppositely between the pair of die rolls, In the method of manufacturing the soft capsule containing the contents inside the outer skin portion formed by supplying the contents to the outer skin sheet according to the joining, and supplying the contents to the outer skin sheet in accordance with the joining. When the outer sheets are joined by the butting action, the temperature of the segment part for applying heat to the outer sheets is 30 to 40 ° C.
 また請求項8のソフトカプセルは、前記請求項1、2、3、4、5、6または7記載のソフトカプセルの製造方法によって製造されたことを特徴として成るものである。 The soft capsule according to claim 8 is manufactured by the soft capsule manufacturing method according to claim 1, 2, 3, 4, 5, 6 or 7.
 本発明者らは、先にゲル化することのないλカラギーナンに一定量のクエン酸三ナトリウムなどの金属塩を加えたときに、λカラギーナンに適度な粘性と弾性力が得られ、ソフトカプセル形成に好適な組成物が得られることを見出し、従来にない植物性素材を用いた非動物由来のカプセル外皮並びにこれを有したソフトカプセルを完成させた。
 そして、さらにロータリーダイ式自動ソフトカプセル製造機に、中波長赤外線照射によるカプセル外皮シート乾燥装置を組み合わせて、乾燥能力を増強してカプセル外皮シートの水分含量を自在に調整可能な新たなソフトカプセル製造装置を開発して本発明のソフトカプセル製造手法に至った。
 本発明のソフトカプセル製造手法によれば、澱粉、λカラギーナン、金属塩、可塑剤及び水を用いた非動物由来カプセル外皮を有するソフトカプセルの製造において、
 一定量のクエン酸三ナトリウムなどの金属塩を加えるという新たな製造手法に加え、さらに、従来のロータリーダイ式自動ソフトカプセル製造手法に、中波長赤外線照射によるカプセル外皮シート乾燥手法を採り入れ、乾燥能力を増強してカプセル外皮シートの水分含量を自在に調整可能とした新たなカプセル製造手法を開発することにより、
カプセル外皮溶液の脱泡性、流動性を向上させるために水分配合量を多く(澱粉100重量部に対し、90~200重量部)して低粘度でカプセル外皮溶液を仕込んでも、カプセル外皮シートの接着面を均一にムラなく適度な水分含量に乾燥でき、カプセル泡不良の防止、カプセル充填速度アップなど生産性、コスト面の向上を実現し、さらには、従来技術で問題になっていた、カプセル形成後の経時的な硬度低下を防止して硬度安定性を向上させることができる。
When the present inventors added a certain amount of a metal salt such as trisodium citrate to λ carrageenan that does not gel before, moderate viscosity and elastic force are obtained for λ carrageenan, and soft capsule formation is achieved. The inventors found that a suitable composition can be obtained, and completed a non-animal-derived capsule shell using an unprecedented vegetable material and a soft capsule having the capsule shell.
In addition, a new soft capsule manufacturing device that can adjust the moisture content of the capsule shell sheet freely by increasing the drying capacity by combining the rotary die type automatic soft capsule manufacturing machine with the capsule shell sheet drying device using medium wavelength infrared irradiation. Development has led to the soft capsule manufacturing method of the present invention.
According to the soft capsule production method of the present invention, in the production of a soft capsule having a non-animal derived capsule shell using starch, λ carrageenan, metal salt, plasticizer and water,
In addition to a new manufacturing method of adding a certain amount of metal salt such as trisodium citrate, the conventional rotary die type automatic soft capsule manufacturing method adopts a capsule skin sheet drying method by mid-wavelength infrared irradiation to increase the drying capacity. By developing a new capsule manufacturing method that can be adjusted to freely adjust the moisture content of the capsule skin sheet,
In order to improve the defoaming property and fluidity of the capsule shell solution, even if the amount of water is increased (90 to 200 parts by weight with respect to 100 parts by weight of starch) and the capsule shell solution is charged with a low viscosity, Capable of drying the adhesive surface uniformly and uniformly to an appropriate water content, preventing capsule foam failure, increasing capsule filling speed, and improving productivity and cost. It is possible to improve hardness stability by preventing a decrease in hardness over time after formation.
 本発明のソフトカプセル製造手法により製造される非動物由来ソフトカプセルの外皮部は、構成成分組成として澱粉、λカラギーナン、クエン酸三ナトリウムなどの金属塩、可塑剤及び水を配合して形成されるものであり、乾燥前の外皮溶液段階で(外皮部を乾燥させる前の溶液段階で)、澱粉100重量部に対し、前記水の配合量が、好ましくは90~200重量部、より好ましくは110~180重量部、とりわけ好ましくは120~170重量部である。90重量部以下だと、高粘度でカプセル外皮溶液中に溶け込んだエアが抜けにくく、脱泡工程において、エアの脱泡が不十分となり、その結果カプセル外皮シートに泡がある泡不良のカプセルが形成されやすくなる。またカプセル外皮溶液の流動性が悪くなり、カプセル充填速度アップの妨げになり好ましくない。一方、200重量部以上だと、カプセル外皮シートが、やわらかくなりすぎてキャスティングドラムから剥離されにくくなり好ましくない。 The outer skin part of the non-animal derived soft capsule produced by the soft capsule production method of the present invention is formed by blending a metal salt such as starch, λ carrageenan, trisodium citrate, a plasticizer and water as a component composition. Yes, the amount of water is preferably 90 to 200 parts by weight, more preferably 110 to 180 parts per 100 parts by weight of starch in the skin solution stage before drying (in the solution stage before drying the skin part). Part by weight, particularly preferably 120 to 170 parts by weight. If it is 90 parts by weight or less, the air dissolved in the capsule shell solution is difficult to escape, and in the defoaming process, the defoaming of the air becomes insufficient. It becomes easier to form. Further, the fluidity of the capsule shell solution is deteriorated, which hinders the increase in capsule filling speed, which is not preferable. On the other hand, if it is 200 parts by weight or more, the capsule skin sheet becomes too soft and is difficult to peel off from the casting drum.
 澱粉100重量部に対し、水配合量90~200重量部の粘度(λカラギーナン、金属塩、可塑剤の配合は無し)は、濃度10%、温度85~95℃で6時間溶解させた後75℃で測定して1500~13000(低粘度)である。
 一方、澱粉100重量部に対し、水配合量60~90重量部の粘度(λカラギーナン、金属塩、可塑剤の配合は無し)は、濃度10%、85~95℃で6時間溶解させた後75℃で測定して13000~35000(高粘度)である。なお、粘度は株式会社トキメック製のB型粘度計を用いて測定した。
The viscosity of 90 to 200 parts by weight of water based on 100 parts by weight of starch (λ carrageenan, metal salt, and plasticizer are not added) is 75% after dissolving at a concentration of 10% and a temperature of 85 to 95 ° C. for 6 hours. It is 1500-13000 (low viscosity) measured at ° C.
On the other hand, a viscosity of 60 to 90 parts by weight of water based on 100 parts by weight of starch (with no addition of λ carrageenan, metal salt or plasticizer) was dissolved at a concentration of 10% at 85 to 95 ° C. for 6 hours. It is 13000-35000 (high viscosity) measured at 75 ° C. The viscosity was measured using a B-type viscometer manufactured by Tokimec Co., Ltd.
 本発明に使用する金属塩はクエン酸三ナトリウムが好適に用いられ、クエン酸三ナトリウムの他、コハク酸ナトリウム、グルコン酸ナトリウム、リン酸水素二ナトリウム、リン酸二水素ナトリウム、塩化カリウム、塩化マグネシウムからなる群から選ばれる1種類又は2種類以上の組み合わせで用いられる。その中でも、クエン酸三ナトリウム、または、クエン酸三ナトリウムとリン酸二水素ナトリウムの組み合わせ、または、クエン酸三ナトリウムと塩化カリウムの組み合わせ、またはクエン酸三ナトリウムとリン酸二水素ナトリウムと塩化カリウムの組み合わせが好適に用いられる。
 クエン酸三ナトリウムの配合比率は、乾燥前の外皮溶液段階で(外皮部を乾燥させる前の溶液段階で)、澱粉100重量部に対して、1~20重量部、好ましくは2~15重量部、とりわけ好ましくは5~10重量部である。クエン酸三ナトリウムが1重量部以下だと、ソフトカプセルを形成後のカプセル硬度の経時的な低下を防止することができない。一方、ナトリウム塩が20重量部以上だと、ナトリウム塩濃度が高くなるため、健康食品のソフトカプセル外皮として好ましくない。
 クエン酸三ナトリウムとその他の金属塩を組み合わせて用いる時の、その他の金属塩の配合比率は、乾燥前の外皮溶液段階で(外皮部を乾燥させる前の溶液段階で)、澱粉100重量部に対して、リン酸二水素ナトリウムが1~5重量部、塩化カリウムが0.01~0.3重量部で好適に用いられる。さらに好ましくはリン酸二水素ナトリウムが1.5~3重量部、塩化カリウムが0.03~0.15重量部である。リン酸二水素ナトリウムが5重量部以上だと、λカラギーナンが加水分解する可能性があるため好ましくない。
The metal salt used in the present invention is preferably trisodium citrate. In addition to trisodium citrate, sodium succinate, sodium gluconate, disodium hydrogen phosphate, sodium dihydrogen phosphate, potassium chloride, magnesium chloride One type selected from the group consisting of or a combination of two or more types. Among them, trisodium citrate, or a combination of trisodium citrate and sodium dihydrogen phosphate, or a combination of trisodium citrate and potassium chloride, or trisodium citrate, sodium dihydrogen phosphate and potassium chloride. Combinations are preferably used.
The mixing ratio of trisodium citrate is 1 to 20 parts by weight, preferably 2 to 15 parts by weight with respect to 100 parts by weight of starch in the skin solution stage before drying (in the solution stage before drying the skin part). Particularly preferred is 5 to 10 parts by weight. When trisodium citrate is 1 part by weight or less, it is impossible to prevent a decrease in capsule hardness over time after forming soft capsules. On the other hand, when the sodium salt is 20 parts by weight or more, the sodium salt concentration increases, which is not preferable as a soft capsule skin for health food.
When trisodium citrate and other metal salts are used in combination, the blending ratio of other metal salts is 100 parts by weight of starch at the outer skin solution stage before drying (at the solution stage before drying the outer skin part). On the other hand, 1 to 5 parts by weight of sodium dihydrogen phosphate and 0.01 to 0.3 parts by weight of potassium chloride are preferably used. More preferably, sodium dihydrogen phosphate is 1.5 to 3 parts by weight and potassium chloride is 0.03 to 0.15 parts by weight. It is not preferable that sodium dihydrogen phosphate is 5 parts by weight or more because λ carrageenan may be hydrolyzed.
〔クエン酸三ナトリウム添加と中波長赤外線照射の作用効果〕
 本発明者らは、ゲル化することのないλカラギーナンに一定量のクエン酸三ナトリウムを加えることによってλカラギーナンに適度な粘性と弾力性を与え、クエン酸三ナトリウム添加と中波長赤外線照射を組み合わせることで、カプセル形成後の経時的な硬度低下を防止して硬度安定性を向上させることを見出した。
 本発明においては、金属塩としてクエン酸三ナトリウムのみを用いても、中波長赤外線照射でカプセル外皮シートの水分含量を自在に調整可能とした新たなカプセル製造手法により、カプセル外皮溶液の脱泡性、流動性を向上させるために水分配合量を多く(澱粉100重量部に対し、90~200重量部)して低粘度でカプセル外皮溶液を仕込んでも、カプセル外皮シートの接着面を均一にムラなく適度な水分含量に乾燥でき、カプセル泡不良の防止、カプセル充填速度アップなど生産性、コスト面の向上を実現し、さらには、従来技術で問題になっていた、カプセル形成後の経時的な硬度低下を防止して硬度安定性を向上させることができる。
[Effects of trisodium citrate addition and mid-wavelength infrared irradiation]
The present inventors give moderate viscosity and elasticity to λ carrageenan by adding a certain amount of trisodium citrate to λ carrageenan that does not gel, and combines trisodium citrate addition with medium wavelength infrared irradiation Thus, the present inventors have found that the hardness stability is improved by preventing a decrease in hardness over time after capsule formation.
In the present invention, even if only trisodium citrate is used as the metal salt, the defoaming property of the capsule shell solution is achieved by a new capsule manufacturing method that allows the moisture content of the capsule shell sheet to be freely adjusted by irradiation with medium wavelength infrared rays. In order to improve fluidity, even if the water content is increased (90 to 200 parts by weight with respect to 100 parts by weight of starch) and the capsule skin solution is charged with a low viscosity, the adhesive surface of the capsule skin sheet is evenly uniform. It can be dried to an appropriate water content, and it can improve the productivity and cost, such as prevention of capsule foam failure, increase the capsule filling speed, and the time-lapse hardness after capsule formation, which has been a problem in the prior art. Decrease can be prevented and hardness stability can be improved.
 一方、本発明においては金属塩としてクエン酸三ナトリウムの他、リン酸二水素ナトリウムと塩化カリウムなどを組み合わせて用いても、クエン酸三ナトリウムの作用効果を阻害するものではなく、適宜クエン酸三ナトリウム以外の金属塩を使用することができる。その作用効果は必ずしも明らかではないが、リン酸二水素ナトリウムと塩化カリウムを加えた時の例を示す。
 (1)リン酸二水素ナトリウムなどの弱酸性金属塩の機能
 λカラギーナンは陰イオン性高分子であるので、陽イオン(H、Na)存在下で可溶化し透明になるという性質を持っている。この陰イオン性高分子であるλカラギーナンにリン酸二水素ナトリウムなどの弱酸性金属塩を加え、加水分解が起きずに適度な粘性(接着性)が得られるようにする。
(2)塩化カリウム、クエン酸カリウムなどの金属塩の機能
 弱酸性下にある陰イオン高分子であるλカラギーナンに、塩化カリウムなどでK(カリウムイオン)を供給することにより、Kを中心として、陰イオン性高分子であるλカラギーナンが、錯体のようなものを形成して弾性力を増強する。
(3)澱粉の機能
 シートが適度な粘性(接着性)と弾性力を有する溶融状態で、糊化された澱粉が、澱粉糊作用によるシール性を有するために、(i)金型(後述するダイロール)による圧着、(ii)澱粉糊による溶着によりソフトカプセルが形成される。
 なお、本発明のクエン酸三ナトリウムなどの金属塩添加と中波長赤外線照射を組み合わせることで製造される非動物由来ソフトカプセルは、本事例に限定されるものではなく、κカラギーナンやιカラギーナンが含まれていても、λカラギーナンヘのクエン酸三ナトリウム添加の作用効果を阻害するものではない。
On the other hand, in the present invention, the use of trisodium citrate as a metal salt in combination with sodium dihydrogen phosphate and potassium chloride does not inhibit the action and effect of trisodium citrate. Metal salts other than sodium can be used. Although the effect is not necessarily clear, an example is shown when sodium dihydrogen phosphate and potassium chloride are added.
(1) Functions of weakly acidic metal salts such as sodium dihydrogen phosphate Since λ carrageenan is an anionic polymer, it has the property of being solubilized and transparent in the presence of cations (H + , Na + ). ing. A weakly acidic metal salt such as sodium dihydrogen phosphate is added to λ carrageenan, which is an anionic polymer, so that an appropriate viscosity (adhesiveness) can be obtained without hydrolysis.
(2) Functions of metal salts such as potassium chloride and potassium citrate By supplying K + (potassium ion) with potassium chloride to λ carrageenan, which is an anionic polymer under weak acidity, mainly K + As described above, λ carrageenan, which is an anionic polymer, forms a complex to enhance the elastic force.
(3) Function of starch (i) Mold (to be described later) in order that the gelatinized starch has a sealing property due to starch paste action in a molten state where the sheet has an appropriate viscosity (adhesiveness) and elasticity. Soft capsules are formed by pressure bonding with (die roll) and (ii) welding with starch paste.
Note that the non-animal derived soft capsules produced by combining the addition of a metal salt such as trisodium citrate according to the present invention and medium wavelength infrared irradiation are not limited to this example, and include κ carrageenan and ι carrageenan. However, the effect of adding trisodium citrate to λ carrageenan is not inhibited.
 κカラギーナン及びιカラギーナンの性質として、前述した非特許文献1には、「κ一またはι-カラギーナンを水に分散し、約60℃以上に加熱すると、カラギーナンの分子はランダムコイル状に溶解する。この溶液を冷却していくとダブルヘリックスが形成され、これがジャンクションゾーンとなってゲル化が始まる。」と記載されている。このような物性をもつため、ιカラギーナン及びκカラギーナンを用いてカプセル化皮膜を形成する際には、カプセル化皮膜としてゼラチンを用いる際(セグメント部温度:通常35~50℃)よりも、カプセル化皮膜シートを少なくとも20~30℃分高い温度で加熱しなければならない。そのため、カプセル内容物への熱負荷が大きく品質上問題があり、また熱エネルギー効率が悪いなどの課題があった。
 しかし、本発明者らは、ゲル化することのないλカラギーナンに一定量の金属塩を加えることによってλカラギーナンに適度な粘性と弾力性を持つことを見出し、非動物由来ソフトカプセルを完成させた。そのため、κカラギーナン、ιカラギーナンとは異なり、λカラギーナンでカプセル化皮膜を形成する際には、ゼラチンを用いる際(セグメント部温度:通常35~50℃)と同程度(セグメント部温度:30~40℃)のセグメント部温度で、カプセル内容物に過度な熱負荷をかけることなくカプセル化でき、熱エネルギー効率が良いなどの利点がある。
 またλカラギーナンの配合比率は、乾燥前の外皮溶液段階で、澱粉100重量部に対して、5~25重量部、より好ましくは7~20重量部、とりわけ好ましくは10~15重量部である。
Regarding the properties of κ carrageenan and ι carrageenan, Non-Patent Document 1 described above states that “When κ- or ι-carrageenan is dispersed in water and heated to about 60 ° C. or higher, the carrageenan molecules dissolve in a random coil shape. When this solution is cooled, a double helix is formed, which becomes a junction zone and gelation begins. " Because of these physical properties, when forming an encapsulated film using ι carrageenan and κ carrageenan, encapsulation is performed more than when gelatin is used as the encapsulated film (segment temperature: usually 35 to 50 ° C.). The coated sheet must be heated at a temperature that is at least 20-30 ° C. higher. For this reason, there is a problem that the heat load on the capsule contents is large and there is a problem in quality, and the thermal energy efficiency is poor.
However, the present inventors have found that λ carrageenan has an appropriate viscosity and elasticity by adding a certain amount of metal salt to λ carrageenan that does not gel, and completed a non-animal derived soft capsule. Therefore, unlike κ carrageenan and ι carrageenan, when forming an encapsulated film with λ carrageenan, the same level as when gelatin is used (segment temperature: usually 35 to 50 ° C.) (segment temperature: 30 to 40). At a segment temperature of (° C.), the capsule contents can be encapsulated without applying an excessive heat load, and the heat energy efficiency is good.
The blending ratio of λ carrageenan is 5 to 25 parts by weight, more preferably 7 to 20 parts by weight, and particularly preferably 10 to 15 parts by weight with respect to 100 parts by weight of starch at the stage of the skin solution before drying.
 本発明の非動物由来ソフトカプセルの外皮部構成成分である澱粉は、生澱粉、HP化澱粉、酸処理澱粉及びα化澱粉からなる群から選ばれる1種類又は2種類以上の組み合わせである。 
 ここで、澱粉誘導体であるHP化澱粉とは、ヒドロキシプロピルエーテル化澱粉であり、市場に販売されているHP化澱粉であればいずれのものでも使用することが出来る。例えば東海澱粉株式会社製の商品名TR-3、松谷化学工業株式会社製の商品名松谷ゆり、ファイネックスAG600、日澱化学株式会社製の商品名デリカKHなどが適用できる。また同じく澱粉誘導体であるα化澱粉とは、常温で糊化(溶解)する冷水可溶性澱粉であり、例えば三和澱粉工業株式会社製の商品名タピオカアルファーTP-2が適用できる。
The starch that is the outer skin component of the non-animal derived soft capsule of the present invention is one type or a combination of two or more types selected from the group consisting of raw starch, HP-modified starch, acid-treated starch and pregelatinized starch.
Here, the HP-modified starch which is a starch derivative is a hydroxypropyl etherified starch, and any HP-modified starch sold on the market can be used. For example, trade name TR-3 manufactured by Tokai Starch Co., Ltd., trade name Matsutani Yuri, Finex AG600 manufactured by Matsutani Chemical Industry Co., Ltd., trade name Delica KH manufactured by Nissho Chemical Co., Ltd. can be applied. Similarly, the pregelatinized starch, which is a starch derivative, is a cold water soluble starch that is gelatinized (dissolved) at room temperature. For example, trade name Tapioca Alpha-TP-2 manufactured by Sanwa Starch Co., Ltd. can be applied.
 本発明の非動物由来ソフトカプセルの外皮部構成成分として、澱粉と共に更に澱粉分解物も配合して使用することができる。ここで澱粉分解物とは、デキストリン、マルトデキストリン、還元デキストリン、シクロデキストリン、オリゴ糖、ポリデキストロースからなる群から選ばれる1種類又は2種類以上の組み合わせであり、市場に販売されている澱粉分解物であればいずれのものでも使用することが出来る。例えば、松谷化学工業株式会社製の商品名 パインデックス♯1(デキストリン)、パインデックス♯2(マルトデキストリン)、H-PDX(還元デキストリン)が使用できる。
 また澱粉分解物の配合比率は、乾燥前の外皮溶液段階で、澱粉100重量部に対して、1~80重量部、より好ましくは5~50重量部、とりわけ好ましくは10~30重量部である。
As a constituent component of the outer skin of the non-animal-derived soft capsule of the present invention, a starch decomposition product can be further used together with starch. Here, the starch degradation product is one or a combination of two or more selected from the group consisting of dextrin, maltodextrin, reduced dextrin, cyclodextrin, oligosaccharide, and polydextrose, and is a starch degradation product sold in the market. Any of them can be used. For example, trade names Paindex # 1 (dextrin), Paindex # 2 (maltodextrin), and H-PDX (reduced dextrin) manufactured by Matsutani Chemical Co., Ltd. can be used.
The blending ratio of the starch degradation product is 1 to 80 parts by weight, more preferably 5 to 50 parts by weight, and particularly preferably 10 to 30 parts by weight with respect to 100 parts by weight of starch in the outer skin solution stage before drying. .
 本発明に使用できる可塑剤は、グリセリン、糖アルコール、プロピレングリコール、ポリエチレングリコール、二糖類、オリゴ糖、イソマルトオリゴ糖などである。また可塑剤の配合比率は、乾燥前の外皮液段階で、澱粉100重量部に対して、20~250重量部、より好ましくは30~80重量部、とりわけ好ましくは35~70重量部である。 The plasticizer that can be used in the present invention is glycerin, sugar alcohol, propylene glycol, polyethylene glycol, disaccharide, oligosaccharide, isomaltoligosaccharide and the like. The blending ratio of the plasticizer is 20 to 250 parts by weight, more preferably 30 to 80 parts by weight, and particularly preferably 35 to 70 parts by weight with respect to 100 parts by weight of starch at the stage of the skin solution before drying.
本発明のソフトカプセル製造手法によれば、澱粉、λカラギーナン、金属塩、可塑剤及び水を用いた非動物由来カプセル外皮を有するソフトカプセルの製造において、金属塩として一定量以上のクエン酸三ナトリウムを加えるという新たな製造手法に加え、さらに、従来のロータリーダイ式自動ソフトカプセル製造手法に、中波長赤外線照射によるカプセル外皮シート乾燥手法を採り入れ、乾燥能力を増強してカプセル外皮シートの水分含量を自在に調整可能とした新たなカプセル製造手法を開発することにより、
カプセル外皮溶液の脱泡性、流動性を向上させるために水分配合量を多く(澱粉100重量部に対し、90~200重量部)して低粘度でカプセル外皮溶液を仕込んでも、カプセル外皮シートの接着面を均一にムラなく適度な水分含量に乾燥でき、カプセル泡不良の防止、カプセル充填速度アップなど生産性、コスト面の向上を実現し、さらには、従来技術で問題になっていた、カプセル形成後の経時的な硬度低下を防止して硬度安定性を向上させることができる。
According to the method for producing a soft capsule of the present invention, in the production of a soft capsule having a non-animal-derived capsule shell using starch, λ carrageenan, a metal salt, a plasticizer and water, a certain amount or more of trisodium citrate is added as a metal salt. In addition to the new manufacturing method, the conventional rotary die type automatic soft capsule manufacturing method adopts the capsule skin sheet drying method by mid-wavelength infrared irradiation to enhance the drying capacity and freely adjust the moisture content of the capsule skin sheet By developing a new capsule manufacturing method that made possible,
In order to improve the defoaming property and fluidity of the capsule shell solution, even if the amount of water is increased (90 to 200 parts by weight with respect to 100 parts by weight of starch) and the capsule shell solution is charged with a low viscosity, Capable of drying the adhesive surface uniformly and uniformly to an appropriate water content, preventing capsule foam failure, increasing capsule filling speed, and improving productivity and cost. It is possible to improve hardness stability by preventing a decrease in hardness over time after formation.
本発明で使用するソフトカプセル製造装置(充填機)を示す斜視図、並びに中波長赤外線照射による乾燥装置を正面から示す説明図である。It is the perspective view which shows the soft capsule manufacturing apparatus (filling machine) used by this invention, and explanatory drawing which shows the drying apparatus by medium wavelength infrared irradiation from the front. 本発明で使用する製造装置(充填機)を示す正面図である。It is a front view which shows the manufacturing apparatus (filling machine) used by this invention. 中波長赤外線照射による乾燥装置を拡大して示す斜視図である。It is a perspective view which expands and shows the drying apparatus by medium wavelength infrared irradiation. 一対のダイロールによってソフトカプセルを製造する様子を示す正面図である。It is a front view which shows a mode that a soft capsule is manufactured with a pair of die roll. 一対のダイロールを示す平面図である。It is a top view which shows a pair of die roll. 中波長赤外線照射による乾燥装置を、キャスティングドラムの側傍部に設け(特に移送路は設けることなく)、外皮シートを乾燥するようにした片面乾燥を示す充填機の正面図、並びに乾燥装置部分を示す右側面図である。A front view of a filling machine showing a single-sided drying in which a drying device by mid-wavelength infrared irradiation is provided on the side of the casting drum (particularly without a transfer path) and the outer sheet is dried, and a drying device part It is a right view shown. 中波長赤外線照射による乾燥用の移送路を4段階に設け、外皮シートのオモテ面とウラ面とを各々2回ずつ乾燥(照射)できるようにした両面乾燥を示す充填機の正面図である。FIG. 4 is a front view of a filling machine showing double-sided drying in which a drying transfer path by mid-wavelength infrared irradiation is provided in four stages so that the front and back surfaces of the outer sheet can be dried (irradiated) twice each. 乾燥中の外皮シートをコンベヤによって下方から支えるようにした実施例を示す正面図である。It is a front view which shows the Example which supported the outer skin sheet | seat during drying from the downward direction by the conveyor.
 本発明を実施するための最良の形態は、以下の実施例に述べるものをその1つとするとともに、更にその技術思想内において改良し得る種々の手法を含むものである。
 なお、説明にあたっては、まず本発明に係るソフトカプセル1の基本構造について説明した後、このソフトカプセル1を製造する装置(本発明で使用する装置)の一例について説明する。次いで、この装置の作動態様について説明しながら、併せて本発明方法であるソフトカプセルの製造方法について説明し、更にカプセル外皮の成分組成を実際に示しながら、詳細に説明する。
BEST MODE FOR CARRYING OUT THE INVENTION The best mode for carrying out the present invention includes one described in the following examples, and further includes various methods that can be improved within the technical idea.
In the description, first, the basic structure of the soft capsule 1 according to the present invention will be described, and then an example of a device for manufacturing the soft capsule 1 (device used in the present invention) will be described. Next, while explaining the operation mode of this apparatus, the production method of the soft capsule which is the method of the present invention will be explained together, and further the detailed explanation will be given while actually showing the component composition of the capsule shell.
 〔ソフトカプセルの基本構造〕
 ソフトカプセル1の基本構造は、例えば図4に示すように、薬液等の内容物Nを外皮部2で被覆して成るものである。
 ここで内容物Nとしては、医薬品の他、食品、調味料(調味油)、化粧品、入浴剤、雑貨(玩具・接着剤等)など適宜の目的の材料を用いることができる。また、その内包状態(収容状態)としては、液体状の他、ゲル状、粉粒体、あるいは適宜これらを混入した状態、例えば液体中に粉体を混合させた粉体含有懸濁液等とすることが可能である。なお以下の説明においては、主に液体状の内容物Nを収容する場合について説明する。
 一方、外皮部2は、従来のように、動物由来のゼラチンを基材とすることも可能であるが、ここでは上述したように植物由来の澱粉を主成分とするものであり、具体的には澱粉、λカラギーナン、金属塩、可塑剤、及び水を配合して形成されるものである。なお、これらの具体的な成分組成等については後述する。
[Basic structure of soft capsule]
The basic structure of the soft capsule 1 is, for example, as shown in FIG.
Here, as the contents N, materials for appropriate purposes such as foods, seasonings (seasoning oils), cosmetics, bathing agents, miscellaneous goods (toys, adhesives, etc.) can be used in addition to pharmaceuticals. In addition, the encapsulated state (accommodating state) includes a liquid form, a gel form, a granular body, or a state in which these are appropriately mixed, for example, a powder-containing suspension in which powder is mixed in a liquid. Is possible. In the following description, a case where the liquid content N is mainly stored will be described.
On the other hand, the outer skin part 2 can be based on animal-derived gelatin as in the past, but here, as described above, it is mainly composed of plant-derived starch, and specifically, Is formed by blending starch, λ carrageenan, metal salt, plasticizer, and water. The specific composition of these components will be described later.
 〔製造装置について〕
 次に、このようなソフトカプセル1を製造するソフトカプセル製造装置10(以下、単に充填機10とする)について説明する。充填機10としては、従来のロータリーダイ式自動ソフトカプセル製造機が流用(踏襲)でき、一例として図1に示すように、溶融状態の外皮原料(外皮部2を形成する原料素材であることに因み、2Aと付す)を乾燥しながら適宜の厚さのシート状に形成するシート成形部11と、成形した外皮シートSを拝み合わせ状態に接合することによって外皮シートSで内容物Nをカプセル状に包むカプセル成形部12と、外皮シートSの接合に合わせて内容物Nを送り込む内容物供給部13と、形成されたソフトカプセル1を充填機10から取り出すカプセル取出部14とを具えて成るものである。
 なお、本発明では、シート成形部11に、中波長赤外線照射による乾燥装置15を設け、従来の製造手法に比べ乾燥能力を格段に向上させた点が大きな特徴である。以下、各構成部について説明する。
[About manufacturing equipment]
Next, a soft capsule manufacturing apparatus 10 (hereinafter simply referred to as a filling machine 10) for manufacturing such a soft capsule 1 will be described. As the filling machine 10, a conventional rotary die type automatic soft capsule manufacturing machine can be diverted (followed), and as an example, as shown in FIG. 1, it is a raw material for forming a molten outer shell material (a raw material material for forming the outer skin portion 2). 2A), the contents N are encapsulated in the outer sheet S by joining the formed outer sheet S and the sheet forming part 11 formed into a sheet with an appropriate thickness while drying. A capsule forming part 12 for wrapping, a content supply part 13 for feeding the contents N in accordance with the joining of the outer skin sheet S, and a capsule take-out part 14 for taking out the formed soft capsule 1 from the filling machine 10. is there.
The present invention is characterized in that the sheet forming unit 11 is provided with a drying device 15 using medium wavelength infrared irradiation, and the drying ability is remarkably improved as compared with the conventional manufacturing method. Hereinafter, each component will be described.
 まず、シート成形部11について説明する。このものは、溶融状態の外皮原料2Aをシート状に固化形成する部位であり、成形された二枚の外皮シートSを接合部(一対のダイロール間)に拝み合わせ状態に供給するため、一例としてカプセル成形部12を挟んで左右に一対設けられる。シート成形部11は、溶融状態の外皮原料2Aを、ほぼ一定の厚さのシート状態で吐き出すスプレダーボックス21と、このスプレダーボックス21から吐き出された外皮シートSを冷却するキャスティングドラム22とを具えて成り、外皮シートSはここで適宜の温度に冷やされながら適宜の厚さのシート状に成形される。なお、外皮原料2Aを溶解する手法については後述する。 First, the sheet forming part 11 will be described. This is a part that solidifies and forms the raw material 2A in the form of a sheet. In order to supply the two outer sheets S formed to the joining portion (between a pair of die rolls), A pair is provided on the left and right with the capsule forming part 12 in between. The sheet forming unit 11 includes a spreader box 21 that discharges the melted skin raw material 2A in a substantially constant sheet state, and a casting drum 22 that cools the skin sheet S discharged from the spreader box 21. The outer sheet S is formed into a sheet having an appropriate thickness while being cooled to an appropriate temperature. A method for dissolving the outer shell raw material 2A will be described later.
 ここで、上記乾燥装置15について説明する。乾燥装置15は、外皮原料2Aからシート状に固化形成された外皮シートSを乾燥させ、所望の水分含量に調整するためのものである。なお、このような乾燥を外皮シートSに施し水分含量を調整するのは、後段の接合において、シート同士の接着性(接合性)を高めるためである。さらに、カプセル形成後の経時的な硬度低下を防止して硬度安定性を向上させることができるものである。また、図1に示す実施例では、キャスティングドラム22の上方に形成した乾燥装置本体15A内において、外皮シートSの両面に別々に中波長赤外線を照射して、外皮シートSの乾燥を図るものである(これを両面乾燥とする)。因みに、ここでは前記キャスティングドラム22に直接付着しなかった面を最初に乾燥し(これを便宜上、オモテ面乾燥とする)、その後、キャスティングドラム22に直接付着した面を乾燥するものである(これを便宜上、ウラ面乾燥とする)。なお、これらオモテ面乾燥/ウラ面乾燥を別の観点から見れば、最終的にソフトカプセル1とした状態においてカプセル外側に相当する面の乾燥がオモテ面乾燥となり、カプセル内側に相当する面つまり内容物Nと直接接触する面の乾燥がウラ面乾燥となる。 Here, the drying device 15 will be described. The drying device 15 is for drying the skin sheet S solidified into a sheet form from the skin raw material 2A and adjusting it to a desired moisture content. The reason why the moisture content is adjusted by applying such drying to the outer sheet S is to improve the adhesiveness (bondability) between the sheets in the subsequent bonding. Furthermore, hardness stability over time after capsule formation can be prevented and hardness stability can be improved. Further, in the embodiment shown in FIG. 1, in the drying apparatus main body 15A formed above the casting drum 22, both surfaces of the outer sheet S are separately irradiated with medium wavelength infrared rays to dry the outer sheet S. Yes (this is double-sided drying). Incidentally, here, the surface not directly attached to the casting drum 22 is first dried (this is referred to as front surface drying for convenience), and then the surface directly attached to the casting drum 22 is dried (this) For the sake of convenience) In addition, when these front surface drying / back surface drying are viewed from another point of view, the surface corresponding to the outer side of the capsule in the state of the soft capsule 1 finally becomes the front surface drying, and the surface corresponding to the inner side of the capsule, that is, the contents Drying the surface in direct contact with N is the back surface drying.
 また、本実施例においては、外皮シートSをキャスティングドラム22から剥離させ、別途、フィードロール23によって移送しながら乾燥するものであり、この移送路を24と付すものである。すなわち、オモテ面乾燥用とウラ面乾燥用との双方の移送路24は、フィードロール23によって外皮シートSの表裏を反転させることにより形成され、シート(表裏)の上方から、一定の距離を維持して中波長赤外線が照射される。このため各移送路24には、中波長赤外線を放射する中波長赤外線ヒーター25が設けられており、また該ヒーターの下方には、外皮シートSを挟んで反射板26が設けられ、非照射面側についても、いくらかの乾燥作用を意図し、熱効率の向上を図っている。
 なお、ここではオモテ面とウラ面との各面について4本(4基)の中波長赤外線ヒーター25を設置しているが、これらは必ずしも全て使用しなくても良く、当初の外皮原料2Aの配合や所望の乾燥水分含量値等に応じて必要な本数を用い、適切なエネルギー量を外皮シートSに照射すればよい。
Further, in this embodiment, the outer sheet S is peeled off from the casting drum 22 and separately dried while being transported by the feed roll 23, and this transport path is denoted by 24. That is, the transfer path 24 for both the front surface drying and the back surface drying is formed by inverting the front and back of the outer sheet S by the feed roll 23, and maintains a certain distance from above the sheet (front and back). Then, the medium wavelength infrared ray is irradiated. For this reason, each transfer path 24 is provided with a medium-wavelength infrared heater 25 that emits medium-wavelength infrared light, and a reflector 26 is provided below the heater with the outer sheet S sandwiched between them. Also on the side, some drying action is intended to improve thermal efficiency.
Here, four (four) medium-wavelength infrared heaters 25 are installed for each of the front and back surfaces, but not all of them may be used. What is necessary is just to irradiate the outer sheet | seat sheet S with an appropriate energy amount using a required number according to a mixing | blending, a desired dry moisture content value, etc.
 また、外皮シートSは、乾燥と同時に中波長赤外線の照射によって加熱も受けるため、乾燥中に熱変形を生じる傾向にある(ヒーター温度は一例として900℃程度)。すなわち、外皮シートSは移送によって、送り方向(移送方向)に常に引っ張り力が掛かるため、加熱によって、送り方向(長手方向)には伸びるように変形し易く、これと直交する幅方向(奥行き方向)には縮むように変形し易い。そして、長手方向の伸びは、外皮シートS自体の自重により、たるみとなって出現し易いため、このたるみを防ぐために、外皮シートSの下方にはローラ等の支持体27が設けられる。   
 なお、図中、移送路24や中波長赤外線ヒーター25等に付加した符号(末尾符号)「A」・「B」は、これらが作用する面つまり外皮シートSのオモテ面側に作用するものに「A」、ウラ面側に作用するものに「B」という符号を付したものである。
Moreover, since the outer sheet | seat S also receives heating by irradiation of mid-wavelength infrared rays simultaneously with drying, it tends to cause thermal deformation during drying (the heater temperature is about 900 ° C. as an example). That is, since the outer sheet S is always pulled in the feed direction (transfer direction) by the transfer, it is easily deformed so as to extend in the feed direction (longitudinal direction) by heating, and the width direction (depth direction) perpendicular thereto. ) Is easy to deform so as to shrink. Since the elongation in the longitudinal direction is likely to appear as a sag due to the weight of the skin sheet S itself, a support 27 such as a roller is provided below the skin sheet S in order to prevent this sag.
In the figure, reference numerals (A and B) added to the transfer path 24, the medium wavelength infrared heater 25, and the like are those acting on the surface on which they act, that is, on the front side of the skin sheet S. “A” is applied to the back side, and “B” is added to it.
 また、乾燥中の外皮シートSの過度の加熱を防ぐために、外皮シートSの表面(つまり中波長赤外線の照射面)には、ここに沿った送風が施される。この送風は、シートの送り方向と同じ方向、すなわち移送方向上流側から下流側に向けて送風が成される。これにより、外皮シートSは適度に冷却され、移送路24内の空気流も安定し(一種の整流作用)、たるみ等の変形もより防止できるものである。
 なお、本実施例では、上流側に設けられるエア吹出体28は、外皮シートSの幅方向に沿って細長状に開口されたスリットノズルタイプであり、この開口からシート表面に沿ったエアを均一に吐き出すように形成されている。一方、下流側に設けられるエア吸込体29は、開口部がエア吹出体28よりも大きく形成されており、広い範囲で吸気できるように形成されている。
 また、上述したように乾燥中は移送路24や外皮シートSの温度が上昇しがちとなるため、中波長赤外線ヒーター25の下側(外皮シートSの直下方)には温度計30が設けられ、温度管理が行えるように考慮されている。
In order to prevent excessive heating of the outer skin sheet S during drying, the surface of the outer skin sheet S (that is, the irradiation surface of the medium wavelength infrared rays) is blown along the air. This blowing is performed in the same direction as the sheet feeding direction, that is, from the upstream side to the downstream side in the transport direction. Thereby, the outer sheet S is appropriately cooled, the air flow in the transfer path 24 is stabilized (a kind of rectifying action), and deformation such as sagging can be further prevented.
In this embodiment, the air blowing body 28 provided on the upstream side is a slit nozzle type that is elongated in the width direction of the skin sheet S, and air along the sheet surface is uniformly distributed from the opening. It is formed to exhale. On the other hand, the air suction body 29 provided on the downstream side is formed so that the opening is larger than the air blowing body 28 and can be sucked in a wide range.
Further, as described above, since the temperature of the transfer path 24 and the outer sheet S tends to rise during drying, the thermometer 30 is provided below the medium wavelength infrared heater 25 (directly below the outer sheet S). It is considered that temperature management can be performed.
 なお、充填機10の操作を行ったり、充填機10の作動を監視する作業者にとっては、中波長赤外線ヒーター25から放射される光(中波長赤外線)を直視しないことが好ましいため、例えば図1の拡大図に示すように、乾燥装置15の側面部分に上下動可能なカバー31を設け、中波長赤外線ヒーター25からの照射光を積極的に遮ることが好ましい。因みに、カバー31を上下動させるにあたって、図1に併せて示すように、予めカバー31に上下方向のスリット32を二ヵ所形成しておくとともに、このスリット32を通して装置フレーム(乾燥装置本体15A)に蝶ボルト33を螺合しておき、蝶ボルト33の締め付け(ねじ込み)/ゆるめ(解除)によってカバー31を上下動させ、また固定を図るものである。
 更に、移送路24が反転する部分つまりエア吹出体28やエア吸込体29が設けられる部位にも、例えば図3に示すようなカバー34を設けることが好ましく、これはカバー31、34によって、乾燥装置本体15A内が外部空間(製造室)と仕切られ、区画された空間とするためである。すなわち、乾燥装置本体15A内をカバー31、34によって仕切ることにより、エア吹出体28からエア吸込体29へのシート表面に沿った送風がより確実に行え(送風エアの分散が防止でき)、乾燥中の外皮シートSに埃等が付着すること等も防止できるものである。なお、図3に示すカバー34は、製造中、内部の様子が外から目視できるように透明な素材で形成され、またコンパクトに折り畳めるように中折れ状態で水平回動できるように形成されている。
For the operator who operates the filling machine 10 or monitors the operation of the filling machine 10, it is preferable not to look directly at the light emitted from the medium wavelength infrared heater 25 (medium wavelength infrared light). As shown in the enlarged view of FIG. 2, it is preferable to provide a cover 31 that can move up and down on the side surface of the drying device 15 to actively block the irradiation light from the medium wavelength infrared heater 25. Incidentally, when the cover 31 is moved up and down, as shown in FIG. 1, two slits 32 in the vertical direction are formed in the cover 31 in advance, and the apparatus frame (dryer main body 15A) is formed through the slits 32. The butterfly bolt 33 is screwed together, and the cover 31 is moved up and down by fastening (screwing) / loosing (release) the butterfly bolt 33 and fixed.
Further, it is preferable to provide a cover 34 as shown in FIG. 3 at a portion where the transfer path 24 is reversed, that is, a portion where the air blowing body 28 and the air suction body 29 are provided. This is because the inside of the apparatus main body 15A is partitioned from the external space (manufacturing room) to be a partitioned space. That is, by partitioning the inside of the drying apparatus main body 15A by the covers 31, 34, the air blowing along the sheet surface from the air blowing body 28 to the air suction body 29 can be performed more reliably (spreading of the blown air can be prevented), and drying. It is also possible to prevent dust and the like from adhering to the inner skin sheet S. The cover 34 shown in FIG. 3 is formed of a transparent material so that the inside can be seen from the outside during manufacture, and is formed so that it can be horizontally rotated in a folded state so that it can be folded compactly. .
 以上述べた部位がシート成形部11となるものであり、この後、外皮シートSが供給されて行く側にカプセル成形部12が設けられるものであって、両成形部を中継するようにフィードロール37が設けられる。すなわちシート成形部11(乾燥装置15)によって適宜の水分含量となった外皮シートSは、複数のフィードロール37の間をジグザグ状に通過しながらカプセル成形部12に送られる。 The portion described above becomes the sheet forming portion 11, and thereafter, the capsule forming portion 12 is provided on the side to which the outer sheet S is supplied, and the feed roll is relayed between the two forming portions. 37 is provided. That is, the outer sheet S having an appropriate moisture content by the sheet forming unit 11 (drying device 15) is sent to the capsule forming unit 12 while passing between the plurality of feed rolls 37 in a zigzag manner.
 次にカプセル成形部12について説明する。このものは、一例として図4、5に示すように左右一対のダイロール38を主要部材として成り、このうち一方のダイロール38が固定され、他方がこの固定されたダイロール38に対し接近離反自在に構成される。
 また各ダイロール38には、その表面に適宜の形状の成形凹部39と、その周縁部に成形突起40が形成されるものであって、例えば、ほぼ紡錘状ないしは略回転楕円形状を呈するソフトカプセル1を成形する場合には、この成形凹部39は中央部が凹陥した長円状に形成され得る。ただ、澱粉を主成分とした本実施例の場合には、カプセル成形後のソフトカプセル1の縮みがゼラチンを主成分とした場合よりも激しくなるため、この縮みを予め考慮して、成形凹部39が形成されるものである。そして一対のダイロール38は、互いの成形突起40をほぼ合致させる状態で回転し合うことにより、ダイロール38間に拝み合わせた状態に供給される外皮シートSを引き込みながら、タイミング良く突き合わせ、カプセル周囲の縫合(接合)を行うものである。
Next, the capsule forming part 12 will be described. As an example, as shown in FIGS. 4 and 5, this includes a pair of left and right die rolls 38 as main members, and one of these die rolls 38 is fixed, and the other is configured to be able to approach and separate from the fixed die roll 38. Is done.
Each die roll 38 is provided with a molding recess 39 having an appropriate shape on its surface and a molding projection 40 on its peripheral edge. For example, a soft capsule 1 having a substantially spindle shape or a substantially spheroid shape is provided. In the case of molding, the molding recess 39 can be formed in an oval shape with a recessed central portion. However, in the case of the present embodiment mainly composed of starch, the shrinkage of the soft capsule 1 after the capsule molding becomes more intense than in the case where gelatin is the major component. Is formed. Then, the pair of die rolls 38 rotate in a state where the molding projections 40 substantially match each other, so that the outer sheet S supplied in a state of being entangled between the die rolls 38 is brought into contact with each other in a timely manner. Suture (joining) is performed.
 なお、本実施例では、外皮部2に収容(被覆)される内容物Nとして液体状のものを想定しているため、内容物Nを外皮シートSに向けて送り込む際の噴射圧力(液圧)によって、外皮シートSが成形凹部39に沿うように変形することが期待できる。従って、特に積極的な対策を採ることなく、外皮シートSには、内容物Nの供給(送出)に伴い、内容物Nを受け入れるポケット部Pが自然に形成され得るものである。
 もちろん、内容物Nを供給するまでに、外皮シートSにポケット部Pを積極的に形成することも可能であり、これが例えば図4、5に示す吸引孔41である。すなわち、この場合には、各成形凹部39の底部に形成された吸引孔41からの吸い込みにより、ダイロール38間に送り込まれてくる外皮シートSを積極的に吸引し、内包液Nを受け入れるためのポケット部Pを事前に湾曲形成しておくものである。なお、ポケット部Pを積極的に形成する他の形態としては、例えば内容物Nを供給する以前の段階で、外皮シートSにエンボス加工等を行うことによってポケット部Pを形成することも可能である。因みに、外皮シートSを吸引してポケット部Pを形成する機構については、本出願人が既に特許出願し、特許取得に至っている(特開平10-211257号(特許第3211148号)「粉粒体を内包したゼラチンカプセル並びにその製造方法並びにその製造装置」)。
In the present embodiment, since the liquid N is assumed as the content N to be accommodated (covered) in the outer skin portion 2, the injection pressure (hydraulic pressure) when the content N is fed toward the outer skin S ), The outer sheet S can be expected to be deformed along the molding recess 39. Therefore, the pocket portion P for receiving the content N can be naturally formed in the outer sheet S with the supply (delivery) of the content N without taking a particularly positive measure.
Of course, it is also possible to positively form the pocket portion P in the outer sheet S before supplying the contents N, and this is, for example, the suction hole 41 shown in FIGS. That is, in this case, the outer sheet S sent between the die rolls 38 is actively sucked by suction from the suction holes 41 formed in the bottom of each molding recess 39, and the inclusion liquid N is received. The pocket portion P is curved in advance. As another form of positively forming the pocket portion P, for example, the pocket portion P can be formed by embossing the outer sheet S before the contents N are supplied. is there. Incidentally, regarding the mechanism for sucking the skin sheet S to form the pocket portion P, the present applicant has already applied for a patent and has obtained a patent (Japanese Patent Laid-Open No. 10-2111257 (Patent No. 3211148)). And gelatin manufacturing method and manufacturing apparatus thereof).
 次に内容物供給部13について説明する。このものは、外皮シーSの接合に合わせて、より詳細にはカプセル周囲の縫合が完了する前までに、外皮シートSに対して、液体状等の内容物Nを供給するものであり、先端がダイロール38の間に充分に入り込むように形成された突出状のセグメント44を主要部材として成る。
 内容物供給部13は、一例として図1に示すように、上部に原液ホッパ45を設け、この内部に原液(内容物N)を貯留する。そして原液ホッパ45の下方には、ポンプユニット46を設けるものであって、これは適宜、プランジャ等が多数組み合わされて成り、複数の経路から所定のタイミング、圧力等で内容物Nを噴射させ、デリバリーパイプ47を経由して、セグメント44から外皮シートSに吐き出される。
Next, the content supply unit 13 will be described. This is to supply the contents N such as liquid to the skin sheet S before the sewing around the capsule is completed, more specifically, in accordance with the joining of the skin sheet S. Is a projecting segment 44 formed so as to sufficiently enter between the die rolls 38 as a main member.
As shown in FIG. 1 as an example, the content supply unit 13 is provided with a stock solution hopper 45 in the upper portion, and stores the stock solution (contents N) therein. And below the undiluted solution hopper 45, a pump unit 46 is provided, which is appropriately formed by combining a plurality of plungers, etc., and injecting the content N from a plurality of paths at a predetermined timing, pressure, etc. It is discharged from the segment 44 to the outer sheet S via the delivery pipe 47.
 次にダイロール38の下方において、成形後のソフトカプセル1を取り出すカプセル取出部14について説明する。成形後のソフトカプセル1は、例えば図4に示すように、ダイロール38の成形凹部39に嵌まり込むことが多いため、このようなソフトカプセル1を、ダイロール38に接触するように設けた掻取ブラシ50で掻き落とすとともに、掻き落としたソフトカプセル1をダイロール38の回転軸方向に沿うように設けた一対の前送コンベヤ51によって、充填機10の前面に搬送して取り出すものである(図1参照)。また一対の前送コンベヤ51の間には、一例として図1に示すように、ソフトカプセル1が打ち抜かれた後のブランクシートS´を、両側から挟み込み、そのまま下方に送り込む、フリーローラ52(挟み込み幅が調節自在)を設けるものである。なおこのフリーローラ52は、ソフトカプセル1がブランクシートS´にも残留し得ることを考慮して、ブランクシートS´上にとどまったソフトカプセル1を、どちらかの前送コンベヤ51上に排出し得る構成であることが好ましい。またソフトカプセル1は、前送コンベヤ51によって充填機10の前面まで搬送された後、更に他のコンベヤ53に移載等され、次の乾燥工程に搬送される。 Next, the capsule take-out part 14 for taking out the soft capsule 1 after molding will be described below the die roll 38. For example, as shown in FIG. 4, the soft capsule 1 after molding often fits in the molding concave portion 39 of the die roll 38, and therefore, the scraping brush 50 provided so as to come into contact with the die roll 38. The soft capsule 1 thus scraped off is conveyed to the front surface of the filling machine 10 by a pair of forward conveyors 51 provided along the rotational axis direction of the die roll 38 (see FIG. 1). In addition, as shown in FIG. 1 as an example, a blank sheet S ′ after the soft capsule 1 has been punched is sandwiched between both sides and fed downward as it is between a pair of forward conveyors 51. Is adjustable). The free roller 52 is configured so that the soft capsule 1 remaining on the blank sheet S ′ can be discharged onto one of the forward conveyors 51 in consideration of the fact that the soft capsule 1 may remain on the blank sheet S ′. It is preferable that Moreover, after the soft capsule 1 is conveyed to the front surface of the filling machine 10 by the advance conveyor 51, the soft capsule 1 is further transferred to another conveyor 53 and conveyed to the next drying step.
 なおカプセル成形部12では、二枚の外皮シートSが、一例として図4に示すように、一対のダイロール38間に拝み合わせ状態に送り込まれるとともに、その上方に位置するセグメント44から所定のタイミングで内容物Nが供給される。すなわちダイロール38に供給された二枚の外皮シートSは、その周面に設けられた多数の成形突起40の突き合わせ作用によって、一つずつ個別にカプセル周囲(成形凹部39の周囲)が縫合されて行く。この際、外皮シートSは、成形突起40によって例えば150~200kg程度の圧力を受けるため、縫合部分が効果的に糊化し縫合がなされる。 As shown in FIG. 4, as an example, in the capsule forming unit 12, the two sheet sheets S are fed between the pair of die rolls 38, and at a predetermined timing from the segment 44 positioned above them. Content N is supplied. That is, the two outer sheets S supplied to the die roll 38 are individually stitched around the capsule (around the molding recess 39) one by one by the abutting action of a large number of molding protrusions 40 provided on the peripheral surface. go. At this time, since the outer sheet S is subjected to a pressure of, for example, about 150 to 200 kg by the molding protrusion 40, the stitched portion is effectively glued and stitched.
 そして周囲の縫合が完了したソフトカプセル1は、上述したように成形凹部39やブランクシートS´等から取り出された後、乾燥される。なお、この乾燥においては、ソフトカプセル1の形状やその性状に因み、タンブラー乾燥機(回転ドラム式乾燥機)が一般に使用される。 Then, the soft capsule 1 in which the surrounding stitches have been completed is dried after being taken out from the molding recess 39, the blank sheet S ′, etc. as described above. In this drying, a tumbler dryer (rotary drum dryer) is generally used due to the shape and properties of the soft capsule 1.
 〔製造方法について〕
 本発明で使用するソフトカプセル製造装置10(充填機10)は、以上のような基本構造を有して成り、以下、この充填機10によってソフトカプセル1を製造する態様について説明しながら、併せて本発明方法であるソフトカプセルの製造方法について説明する。
 まず、ソフトカプセル1の外皮部構成成分(外皮原料2A)を、混合して充填機10に供給する態様について説明する。
 一般に、ソフトカプセル1の外皮原料2Aを混合して充填機10に供給するには、バケットタイプの加熱溶解釜を用いる手法と、エクストルーダーによって連続供給する手法とがあり、本発明においても両方を用いることができるが、ここではバッケトタイプの加熱溶解釜を用いた方法について説明する。 
[About manufacturing method]
The soft capsule manufacturing apparatus 10 (filling machine 10) used in the present invention has the basic structure as described above. Hereinafter, the embodiment of manufacturing the soft capsule 1 by the filling machine 10 will be described together with the present invention. A method for producing a soft capsule, which is a method, will be described.
First, the aspect which mixes and supplies the outer skin component component (outer raw material 2A) of the soft capsule 1 to the filling machine 10 will be described.
Generally, in order to mix the shell raw material 2A of the soft capsule 1 and supply it to the filling machine 10, there are a method using a bucket-type heating and melting pot and a method of continuously supplying by an extruder, both of which are also used in the present invention. However, here, a method using a bucket type heating and melting pot will be described.
 例えば、非動物由来のソフトカプセル1を製造する場合、その外皮原料2A溶融する加熱溶解工程は、澱粉、λカラギーナン、金属塩、可塑剤、及び水を加熱溶解釜に入れ0.05~0.3MPa(通常0.2MPa)の圧力下で、攪拌機の回転速度を50~70rpmで攪拌しながら、温度90~120℃(通常110℃)、時間60~100分(通常80分)で加熱溶解する。 For example, when the non-animal-derived soft capsule 1 is manufactured, the heating and melting step of melting the outer shell raw material 2A is performed by placing starch, λ carrageenan, metal salt, plasticizer, and water in a heating and melting pot at 0.05 to 0.3 MPa. Under a pressure of (usually 0.2 MPa), the mixture is heated and dissolved at a temperature of 90 to 120 ° C. (usually 110 ° C.) for a time of 60 to 100 minutes (usually 80 minutes) while stirring at a rotational speed of 50 to 70 rpm.
 次に2段階からなる脱泡工程を行う。1段階目の脱泡工程は、脱泡温度100~110℃(通常105℃)、大気圧を0(ゼロ)としたゲージ圧表記で脱泡圧力-400~-600mmHg(通常-500mmHg)、脱泡時間15~70分(通常30分)で行う。この時最初の5~15分(通常10分)は、攪拌機10rpmで回転させ、その後攪拌機を停止した状態で脱泡する。
 2段階目の脱泡工程は、脱泡温度110~130℃(通常120℃)に上げ、大気圧を0(ゼロ)としたゲージ圧表記で脱泡圧力-400~-600mmHg(通常-500mmHg)、脱泡時間10~20分(通常15分)で脱泡する。
 ここで、加熱溶解工程及び脱泡工程に用いる真空溶解釜としては、特に限定されないが、例えば、商品名:高粘度真空攪拌機(商裕機械有限公司社製、型式:SY-HMD-200)を用いることができる。
 また、脱泡工程に用いる真空ポンプとしては、特に限定されないが、例えば、水封式真空ポンプ(樫山工業株式会社製、型式:LEH100Ms)を用いることができる。
 なお、脱泡後、得られた溶液状態の外皮原料2Aは、耐圧用小分けタンクに移し、60~90℃(通常75℃)で約12~24時間加温保管して用いることが好ましい。
Next, a two-stage defoaming process is performed. The defoaming process in the first stage is performed with a defoaming pressure of −400 to −600 mmHg (usually −500 mmHg), a defoaming pressure expressed as a degassing temperature of 100 to 110 ° C. (usually 105 ° C.), and an atmospheric pressure of 0 (zero). The foaming time is 15 to 70 minutes (usually 30 minutes). At this time, the first 5 to 15 minutes (usually 10 minutes) is rotated with a stirrer of 10 rpm, and then the deaeration is performed with the stirrer stopped.
The defoaming step in the second stage is performed by raising the defoaming temperature to 110 to 130 ° C. (usually 120 ° C.), and defoaming pressure −400 to −600 mmHg (usually −500 mmHg) in the gauge pressure notation where the atmospheric pressure is 0 (zero). Defoaming is performed with a defoaming time of 10 to 20 minutes (usually 15 minutes).
Here, the vacuum melting pot used in the heating and melting step and the defoaming step is not particularly limited. For example, a trade name: high viscosity vacuum stirrer (manufactured by Shoyu Machinery Co., Ltd., model: SY-HMD-200) is used. Can be used.
Moreover, it does not specifically limit as a vacuum pump used for a defoaming process, For example, a water seal type | formula vacuum pump (Kashiyama Kogyo Co., Ltd. make, model: LEH100Ms) can be used.
In addition, after defoaming, it is preferable that the obtained outer raw material 2A in a solution state is transferred to a pressure-resistant subdivision tank and heated and stored at 60 to 90 ° C. (usually 75 ° C.) for about 12 to 24 hours.
 このようにして得た溶液状態の外皮原料2Aを、充填機10に供給する供給工程では、外皮原料2Aを0.01~0.1MPa(通常0.05MPa)の加圧下で小分けタンクより押し出し、充填機10のスプレッダーボックス21に貯留する。またキャスティングドラム22とスプレッダーボックス21の隙間を調整することにより、一定の厚さを保持した外皮シートSを作成する。なお、このときのキャスティングドラム22の温度は、空冷または水冷によって17~22℃(通常温度は20℃)の一定温度に維持される。
 また、このときの充填室湿度(製造室湿度)は、20~26%RH(通常23%RH)の一定湿度に維持し、充填室温度(製造室温度)は、22~27℃(通常25℃)の一定温度に維持することが好ましい。
In the supply step of supplying the solution-state skin raw material 2A thus obtained to the filling machine 10, the skin raw material 2A is extruded from the subdivision tank under a pressure of 0.01 to 0.1 MPa (usually 0.05 MPa), It is stored in the spreader box 21 of the filling machine 10. Further, by adjusting the gap between the casting drum 22 and the spreader box 21, the outer sheet S having a constant thickness is created. The temperature of the casting drum 22 at this time is maintained at a constant temperature of 17 to 22 ° C. (normal temperature is 20 ° C.) by air cooling or water cooling.
The filling chamber humidity (manufacturing chamber humidity) at this time is maintained at a constant humidity of 20 to 26% RH (usually 23% RH), and the filling chamber temperature (manufacturing chamber temperature) is 22 to 27 ° C. (usually 25 ° C.). C)) is preferably maintained at a constant temperature.
 次に、このようにして得た外皮シートSを、中波長赤外線照射による乾燥装置15によって乾燥する態様について説明する。
 スプレッダーボックス21から吐き出された外皮シートSは、キャスティングドラム22に載って、約3/4円(約270度)程度回転した後、キャスティングドラム22から剥離され、その上方等に形成された移送路24に送られ、ここで中波長赤外線照射による両面乾燥を受ける。すなわちキャスティングドラム22から送り出された外皮シートSは、まず移送路24Aを通過する間に、オモテ面(カプセル外側)が中波長赤外線ヒーター25Aによって乾燥され、その後、フィードロール23によって反転させられ、次の移送路24Bに送られて、今度はここでウラ面(カプセル内側)が中波長赤外線ヒーター25Bによって乾燥され、これにより外皮シートSの両面が乾燥される。
Next, an aspect in which the skin sheet S obtained in this way is dried by the drying device 15 using medium wavelength infrared irradiation will be described.
The outer sheet S discharged from the spreader box 21 is placed on the casting drum 22 and rotated about ¾ yen (about 270 degrees), and then peeled off from the casting drum 22 and formed on the upper side thereof. 24, where it undergoes both-side drying by medium wavelength infrared irradiation. That is, the outer sheet S sent out from the casting drum 22 is first dried by the medium wavelength infrared heater 25A while passing through the transfer path 24A, and then reversed by the feed roll 23. This time, the back surface (inside the capsule) is dried by the medium wavelength infrared heater 25B, whereby both sides of the outer sheet S are dried.
 ここで、本発明の外皮シートSの乾燥においては、中波長赤外線ヒーター25から放射される中波長赤外線エネルギーにより、外皮シートSの水分含量が好ましくは30~40%、より好ましくは32~38%、とりわけ好ましくは33~37%になるように乾燥される(水分含量は、株式会社島津製作所製の商品名:MOISTURE BALANCE、型式:MOC-120Hで測定)。これは、外皮シートSの水分含量が、30%より少なくなるか、または40%より多くなると、外皮シートS同士の接着性やカプセル形成後の硬度安定性が落ちる傾向があり好ましくないためである。 Here, in the drying of the outer sheet S of the present invention, the moisture content of the outer sheet S is preferably 30 to 40%, more preferably 32 to 38% by the medium wavelength infrared energy emitted from the medium wavelength infrared heater 25. In particular, it is dried to 33 to 37% (moisture content is measured by Shimadzu Corporation trade name: MOISTURE BALANCE, model: MOC-120H). This is because when the moisture content of the skin sheet S is less than 30% or more than 40%, the adhesion between the skin sheets S and the hardness stability after the capsule formation tend to decrease, which is not preferable. .
 中波長赤外線ヒーター25から放射される中波長赤外線の波長は、好ましくは0.8~4.0μm、より好ましくは1.3~3.0μm、とりわけ好ましくは2.5~2.7μmである。ここで中波長赤外線ヒーター25は、放射される中波長赤外線の波長が前記条件を満たし、市場に販売されているものであればいずれのものでも使用することが出来る。例えば、ヘレウス株式会社製の商品名:中波長赤外線ヒーター、型番:MBS 1600/250が適用できる。 The wavelength of the medium wavelength infrared ray emitted from the medium wavelength infrared heater 25 is preferably 0.8 to 4.0 μm, more preferably 1.3 to 3.0 μm, and particularly preferably 2.5 to 2.7 μm. Here, as the medium wavelength infrared heater 25, any medium wavelength infrared ray can be used as long as the wavelength of the emitted medium wavelength infrared ray satisfies the above conditions and is sold on the market. For example, trade name: medium wavelength infrared heater manufactured by Heraeus Co., Ltd., model number: MBS 1600/250 can be applied.
 なお、本発明では外皮シートSに照射されるものが中波長赤外線であるため、シートの内部まで熱が浸透し、シートの厚さ方向における水分含量を均一にできるものである。そして、このことは、事後のダイロール38による接合が極めて良好に行え、外皮部へのクエン酸三ナトリウム配合と組み合わせることでカプセル形成後の硬度安定性が向上するという点で格別な効果をもたらすものである。
 因みに、単に熱風を外皮シートSに当てて乾燥した場合には、外皮シートSの表面だけが乾燥されてしまい、そのためシート内部と表面とにおいて水分含量の偏り(差)が生じ、その後の接合が良好に行えないことやカプセル形成後の硬度安定性が落ちる傾向があり、これは特に澱粉を主成分とした場合に顕著であった。
In the present invention, since what is irradiated to the outer sheet S is medium-wavelength infrared, heat penetrates into the sheet, and the moisture content in the thickness direction of the sheet can be made uniform. In addition, this provides a particularly advantageous effect in that the subsequent bonding with the die roll 38 can be performed very well, and the hardness stability after the capsule formation is improved by combining with the trisodium citrate compounding to the outer skin part. It is.
By the way, when hot air is simply applied to the outer sheet S and dried, only the surface of the outer sheet S is dried, so that a deviation (difference) in the moisture content occurs between the inside and the surface of the sheet, and the subsequent bonding is performed. There was a tendency that hardness could not be improved and hardness stability after capsule formation was lowered, and this was particularly remarkable when starch was the main component.
 また、本実施例では、中波長赤外線ヒーター25A・25Bの下方に反射板26A・26Bを設けているため、乾燥中の外皮シートSは、中波長赤外線ヒーター25と反射板26との間を通過することになり、熱効率の向上が図られるものである。
 また、外皮シートSは乾燥中、ヒーターからの熱により変形し易いが、本実施例ではローラ等の支持体27により、熱によるたるみが防止されるものである。
 また、外皮シートSの照射面には、シートの移送方向と同じ方向にエアが流されているため、シート温度の過度の上昇が防止されるものである。
In the present embodiment, since the reflection plates 26A and 26B are provided below the medium wavelength infrared heaters 25A and 25B, the outer skin sheet S passing between the medium wavelength infrared heater 25 and the reflection plate 26 passes through. As a result, the thermal efficiency is improved.
In addition, the skin sheet S is easily deformed by heat from the heater during drying, but in this embodiment, the support 27 such as a roller prevents sagging due to heat.
Further, since air is flowed on the irradiation surface of the outer sheet S in the same direction as the sheet transfer direction, an excessive increase in the sheet temperature is prevented.
 このようにして適宜の水分含量に乾燥調整された外皮シートSは、その後、フィードロール37を経由してカプセル成形部12(ダイロール38間)に送り込まれ、ここで接合される。また、これに伴い接合部分の外皮シートSに内容物Nが供給され、外皮部2内に内容物Nを収容したソフトカプセル1が形成される。このようにして形成されたソフトカプセル1は、上述したように、ダイロール38の成形凹部39に嵌まり込んだり、ブランクシートS´に残留するため、ここから取り出され、乾燥される。 The skin sheet S thus dried and adjusted to an appropriate moisture content is then fed into the capsule forming part 12 (between the die rolls 38) via the feed roll 37 and joined there. Further, along with this, the contents N are supplied to the skin sheet S at the joining portion, and the soft capsule 1 containing the contents N is formed in the skin part 2. As described above, the soft capsule 1 formed in this manner is fitted into the molding recess 39 of the die roll 38 or remains in the blank sheet S ′, and is thus taken out and dried.
 なお、カプセル充填速度は、通常ダイロール38(金型)の回転数(rpm:revolution per minute)で表される。澱粉、λカラギーナン、金属塩、可塑剤、及び水を用いた非動物由来のソフトカプセル1の製造においては、中波長赤外線照射による乾燥装置15によって、ダイロール38(金型)の回転数を上げても外皮シートSの水分含量の調整が可能なため、ダイロール38(金型)の回転数を上げて生産性を高めることが可能である。 The capsule filling speed is usually represented by the number of revolutions of the die roll 38 (die) (rpm: revolution per minute). In the production of the non-animal derived soft capsule 1 using starch, λ carrageenan, metal salt, plasticizer, and water, even if the rotational speed of the die roll 38 (mold) is increased by the drying device 15 by the medium wavelength infrared irradiation. Since the moisture content of the outer sheet S can be adjusted, it is possible to increase the productivity by increasing the rotational speed of the die roll 38 (mold).
〔他の実施例〕
 本発明は以上述べた実施例を1つの基本的な技術思想とするものであるが、更に次のような改変が考えられる。すなわち先に述べた実施例は、外皮シートSのオモテ面とウラ面とに作用する移送路24A・24Bを別々に形成し、これらにおいて中波長赤外線ヒーター25A・25Bから中波長赤外線を照射して、外皮シートSの両面を乾燥するものであった。しかしながら、外皮シートSの乾燥が、片側からの照射のみで充分にシート内部まで乾燥できる場合には、どちらか一方の移送路24A・24Bで乾燥を行っても良い。
 もちろん、このような片面乾燥でシート内部まで均一に乾燥できる場合には、移送路24Aを、あえて反転形成する必要がなく、外皮シートSをキャスティングドラム22から剥離した後、接合部(一対のダイロール38間)に送り込むまでの間に、乾燥用(照射用)の移送路24を形成し、ここで中波長赤外線を照射し、乾燥することも可能である。
[Other Examples]
The present invention has the above-described embodiment as one basic technical idea, but the following modifications can be considered. That is, in the embodiment described above, the transfer paths 24A and 24B acting on the front and back surfaces of the outer sheet S are separately formed, and the medium wavelength infrared heaters 25A and 25B are irradiated with the medium wavelength infrared rays in these. The both sides of the skin sheet S were dried. However, when the skin sheet S can be sufficiently dried to the inside of the sheet only by irradiation from one side, it may be dried by either one of the transfer paths 24A and 24B.
Of course, if the sheet can be uniformly dried by such single-sided drying, it is not necessary to reversely form the transfer path 24A, and after the outer sheet S is peeled from the casting drum 22, the joining portion (a pair of die rolls) It is also possible to form a transfer path 24 for drying (irradiation) until it is fed to (between 38) and irradiate it with medium-wavelength infrared rays for drying.
 更に、片面乾燥で乾燥が行える場合には、別途、移送路24を設けずに外皮シートSの乾燥を行うことが可能である。このような乾燥形態としては、例えば図6に示すように、キャスティングドラム22の近傍(ここではスプレッダーボックス21からの吐出後、約1/4円(約90度)回転した位置)に、中波長赤外線ヒーター25を設け、外皮シートSがキャスティングドラム22上に載っている段階(キャスティングドラム22から剥離される前の段階)で乾燥するものである。 Furthermore, when drying can be performed by single-sided drying, it is possible to dry the outer sheet S without providing the transfer path 24 separately. As such a dry form, for example, as shown in FIG. 6, in the vicinity of the casting drum 22 (here, a position rotated about 1/4 circle (about 90 degrees) after being discharged from the spreader box 21), a medium wavelength is used. An infrared heater 25 is provided and is dried at a stage where the outer sheet S is placed on the casting drum 22 (a stage before being peeled from the casting drum 22).
 因みに、上記図6に示す充填機10は、従来のゼラチンを主成分とするソフトカプセル1を製造する場合に好適と考えられる。それは、ゼラチンを主成分とした場合には、中波長赤外線ほどの乾燥能力がなくても充分に乾燥できることも考えられ、従ってこのようなときには中波長赤外線ヒーター25を機能させなければ、特に移送路24がないため従来どおりの乾燥形態、すなわちキャスティングドラム22だけでカプセル外皮シートSの片面(カプセル外側)のみを乾燥する形態(水分量は19~23%)が採れるためである。
 なお、キャスティングドラム22上での片面乾燥は、一見、従来のロータリーダイ式自動ソフトカプセル製造機と同じように思えるかもしれないが、本発明では中波長赤外線の照射であって単なる送風による乾燥ではないため、澱粉、λカラギーナン、金属塩、可塑剤、及び水を含む非動物由来の外皮シートSを充分に乾燥でき、外皮シートSの接着性を高めることができるものである。さらに、カプセル形成後の経時的な硬度低下を防止して硬度安定性を向上させることができるものである。また、外皮シートSの両面を自由自在に乾燥することも可能である。
Incidentally, it is considered that the filling machine 10 shown in FIG. 6 is suitable for manufacturing a soft capsule 1 mainly composed of conventional gelatin. If gelatin is the main component, it may be possible to sufficiently dry even if it does not have a drying capability as high as that of the medium wavelength infrared ray. This is because the conventional dry form, that is, the form in which only one side of the capsule skin sheet S (the outside of the capsule) is dried with only the casting drum 22 (water content is 19 to 23%) can be obtained.
It may seem that the single-sided drying on the casting drum 22 is similar to a conventional rotary die type automatic soft capsule manufacturing machine, but in the present invention, it is irradiation with medium-wavelength infrared rays and not mere air blowing. Therefore, the non-animal derived skin sheet S containing starch, λ carrageenan, metal salt, plasticizer, and water can be sufficiently dried, and the adhesiveness of the skin sheet S can be enhanced. Furthermore, hardness stability over time after capsule formation can be prevented and hardness stability can be improved. It is also possible to freely dry both sides of the outer sheet S.
 一方、このような片面乾燥に対して、当初の水分配合が高い場合や、より高い乾燥能力が必要な場合も考えられる。このため、そのような場合には、上記図6に示す充填機10に上記図1に示した24A・24Bを更に形成し、キャスティングドラム22上での乾燥(片面乾燥)と、移送路24に取り出しての乾燥(両面乾燥)との双方が行えるようにすることが可能である。
 更に、より一層、高い乾燥能力が要求される場合には、例えば図7に示すように、両面乾燥における移送路24を3段階以上で形成し、例えばオモテ面とウラ面の乾燥を各々2回ずつ行うようにすることが可能である。
 もちろん、このように3段階以上の多段階で中波長赤外線ヒーター25を設けた場合であっても、乾燥にあたっては、必ずしも全段階の中波長赤外線ヒーター25を作用(稼動)させる必要はなく、当初の外皮原料2Aの組成成分や乾燥調整したい所望の水分含量値に応じて、必要な部分だけを作用させることは当然可能である。
On the other hand, there are cases where the initial moisture content is high or higher drying capacity is required for such single-sided drying. For this reason, in such a case, 24A and 24B shown in FIG. 1 are further formed in the filling machine 10 shown in FIG. 6, and drying on the casting drum 22 (single-sided drying) is performed. It is possible to perform both of taking out and drying (double-sided drying).
Furthermore, when a higher drying capacity is required, for example, as shown in FIG. 7, the transfer path 24 in double-sided drying is formed in three or more stages, and for example, the front surface and the back surface are dried twice each. It is possible to do it one by one.
Of course, even when the medium-wavelength infrared heater 25 is provided in three or more stages as described above, it is not always necessary to operate (operate) the medium-wavelength infrared heater 25 at all stages for drying. Naturally, it is possible to allow only necessary portions to act in accordance with the composition component of the outer shell raw material 2A and the desired moisture content value to be dried.
 また、先に述べた図1~図3の実施例では、中波長赤外線が照射されている外皮シートSを下方から受ける支持体27としてローラを適用したが、支持体27としては必ずしもローラに限定されるものではなく、例えば図8に示すように、コンベヤなどでも適用できるものである。なお、ここでのコンベヤは、当然、外皮シートSとほぼ同じ移送速度で駆動されるものである。 1 to 3, the roller is applied as the support 27 that receives the outer sheet S irradiated with the medium wavelength infrared rays from below. However, the support 27 is not necessarily limited to the roller. For example, as shown in FIG. 8, a conveyor or the like can be applied. The conveyor here is naturally driven at the same transfer speed as the outer sheet S.
 次に、より詳細な実施例を示しながら、本発明を更に詳しく説明するが、本発明はこの実施例に限定されるものではなく、植物油、動物油、植物油と動物油の組み合わせ、さらには各油脂類に動植物エキス類及びエキス類粉末を含有する懸濁油など、ありとあらゆる油脂との混合物でカプセル化が可能なもの全てに適用できるものである。
 なお、比較例と実施例の説明に先立ち、比較例と実施例に用いた評価項目と評価法について説明する。
Next, the present invention will be described in more detail with reference to more detailed examples. However, the present invention is not limited to these examples, and vegetable oils, animal oils, combinations of vegetable oils and animal oils, and various fats and oils are also described. It can be applied to all those that can be encapsulated with a mixture of various fats and oils such as suspension oils containing animal and plant extracts and extract powders.
Prior to the description of the comparative examples and examples, the evaluation items and the evaluation methods used in the comparative examples and examples will be described.
(1)接着性評価
顕微鏡による目視での評価を行い、以下のように判定した。
◎:非常に良好な接着、○:接着が良い、△:接着悪い、×:接着しない
(2)液漏れ評価
カプセル1000個を12時間静置後、カプセル内容物が漏洩している「液漏れ」のカプセル球数を求めて、液漏れ率を百分率で算出した。
(3)泡不良評価
外皮シートSに目視で泡があることが確認できる泡不良のカプセルが、カプセル1000個中にある球数を求めて、泡不良率を百分率で算出した。
(4)硬度安定性評価
カプセル水分を6~8%に調整後、1日目、7日目、30日目においてカプセル10個の硬度平均値を、木屋式硬度計(株式会社藤原製作所製、最大加重50kg)を用いて算出して、次のように判定した。なお硬度数値が高いほど加圧に対する強度が強いことを示している。
 ◎:非常に良好な硬度安定性、○:硬度安定性が良い、△:硬度安定性が悪い、×:硬度安定性が非常に悪い
(5) 総合評価
 上述した(1)接着性評価、(2)液漏れ評価、(3)泡不良評価、(4)硬度安定性評価を元にして総合的な評価を行い、以下のように判定した。
 ◎:非常に良好、○:良い、△:やや劣る、×:悪い
(1) Adhesive evaluation Visual evaluation was performed with a microscope, and determination was made as follows.
◎: Very good adhesion, ○: Good adhesion, △: Poor adhesion, ×: No adhesion (2) Liquid leakage evaluation After leaving 1000 capsules for 12 hours, the capsule contents are leaking “Liquid leakage The liquid leakage rate was calculated as a percentage.
(3) Foam failure evaluation The number of spheres in which the capsules with poor foam that can be visually confirmed to have bubbles were found in 1000 capsules was calculated, and the bubble failure rate was calculated as a percentage.
(4) Hardness stability evaluation After the capsule moisture was adjusted to 6-8%, the hardness average value of 10 capsules on the 1st, 7th and 30th days was measured using a Kiya-type hardness meter (manufactured by Fujiwara Seisakusho Co., Ltd.). The maximum weight 50 kg) was calculated and determined as follows. The higher the hardness value, the stronger the strength against pressure.
◎: very good hardness stability, ○: good hardness stability, △: poor hardness stability, x: very poor hardness stability (5) Overall evaluation (1) Adhesive evaluation described above ( Based on 2) liquid leakage evaluation, (3) bubble defect evaluation, and (4) hardness stability evaluation, comprehensive evaluation was performed, and the following determination was made.
◎: Very good, ○: Good, △: Slightly inferior, ×: Bad
〔比較例1・比較例2・比較例3〕
 表1に示したカプセル外皮成分を加熱溶解釜に入れ0.2MPaの圧力下で、攪拌機の回転速度を50~70rpmで攪拌しながら、溶解温度110℃で80分間加熱溶解する。
 次に2段階からなる脱泡工程を行う。1段階目の脱泡工程は、脱泡温度105℃、脱泡圧力は大気圧を0(ゼロ)としたゲージ圧表記で-500mmHg、脱泡時間30分で行う。この時最初の10分は、攪拌機10rpmで回転させ、その後攪拌機を停止した状態で脱泡する。2段階目の脱泡工程は、脱泡温度120℃に上げ、脱泡圧力は大気圧を0(ゼロ)としたゲージ圧表記で-500mmHg、脱泡時間15分で脱泡する。脱泡後得られたソフトカプセル外皮溶液は、小分けタンクに移し、75℃で約15時間保管して用いた。
 充填機としては、従来のロータリーダイ式自動ソフトカプセル製造機を用いた。得られたソフトカプセル外皮溶液を、スプレダーボックスから吐出し、充填機の両側にある冷却ドラムに展延することによりシート状(外皮シート)にした。その外皮シートを充填機に誘導して、内容物(MCT70重量%、レシチン30重量%の混合物)を充填した直後に、金型(ダイロール)により圧着してソフトカプセルを得た。
<充填条件>
キャスティングドラムの温度 :20℃
セグメント部温度:30℃
ダイロール回転数: 比較例1及び比較例2では1.5rpm
             比較例3では3.0rpm
充填室湿度:24%RH
充填室温度:26℃
[Comparative Example 1, Comparative Example 2, Comparative Example 3]
The capsule shell components shown in Table 1 are placed in a heating and melting pot and melted by heating at a melting temperature of 110 ° C. for 80 minutes while stirring at a rotational speed of 50 to 70 rpm under a pressure of 0.2 MPa.
Next, a two-stage defoaming process is performed. The defoaming step in the first stage is performed at a defoaming temperature of 105 ° C. and a defoaming pressure of −500 mmHg and a defoaming time of 30 minutes in terms of gauge pressure with the atmospheric pressure being 0 (zero). At this time, the first 10 minutes is rotated with a stirrer of 10 rpm, and then the deaeration is performed with the stirrer stopped. In the second defoaming step, the defoaming temperature is raised to 120 ° C., and the defoaming pressure is degassed in a gauge pressure notation of −500 mmHg with a defoaming time of 15 minutes. The soft capsule shell solution obtained after defoaming was transferred to a small tank and stored at 75 ° C. for about 15 hours for use.
As a filling machine, a conventional rotary die type automatic soft capsule manufacturing machine was used. The obtained soft capsule skin solution was discharged from a spreader box and spread on cooling drums on both sides of the filling machine to form a sheet (outer sheet). The outer skin sheet was guided to a filling machine, and immediately after the contents (mixture of 70% by weight of MCT and 30% by weight of lecithin) were filled, a soft capsule was obtained by pressure bonding with a die (die roll).
<Filling conditions>
Casting drum temperature: 20 ° C
Segment temperature: 30 ° C
Die roll rotation speed: 1.5 rpm in Comparative Example 1 and Comparative Example 2
In Comparative Example 3, 3.0 rpm
Filling room humidity: 24% RH
Filling chamber temperature: 26 ° C
〔比較例4〕
 表1に示したカプセル外皮成分を加熱溶解釜に入れ0.2MPaの圧力下で、攪拌機の回転速度を50~70rpmで攪拌しながら、溶解温度110℃で80分間加熱溶解する。
 次に2段階からなる脱泡工程を行う。1段階目の脱泡工程は、脱泡温度105℃、脱泡圧力は大気圧を0(ゼロ)としたゲージ圧表記で-500mmHg、脱泡時間30分で行う。この時最初の10分は、攪拌機10rpmで回転させ、その後攪拌機を停止した状態で脱泡する。2段階目の脱泡工程は、脱泡温度120℃に上げ、脱泡圧力は大気圧を0(ゼロ)としたゲージ圧表記で-500mmHg、脱泡時間15分で脱泡する。
脱泡後得られたソフトカプセル外皮溶液は、小分けタンクに移し、75℃で約15時間保管して用いた。
 充填機としては、本発明者らが開発した装置である、中波長赤外線照射によるカプセル外皮シート乾燥装置を具えたソフトカプセル製造機を用いた。
 得られたソフトカプセル外皮溶液を、スプレダーボックスから吐出し、充填機10の両側にある冷却ドラム22に展延することによりシート状(外皮シートS)にした。中波長赤外線ヒーターにより、外皮シートSの水分含量を32%になるよう乾燥しながら、その外皮シートSを充填機10に誘導して、内容物(MCT70重量%、レシチン30重量%の混合物)を充填した直後に、金型(ダイロール26)により圧着してソフトカプセル1を得た。
<充填条件>
キャスティングドラムの温度 :20℃
中波長赤外線ヒーター 
(ヘレウス株式会社製、型番:MBS1600/250):波長2.6μm
セグメント部温度:30℃
ダイロール回転数:3.0rpm
充填室湿度:24%RH
充填室温度:26℃
[Comparative Example 4]
The capsule shell components shown in Table 1 are placed in a heating and melting pot and melted by heating at a melting temperature of 110 ° C. for 80 minutes while stirring at a rotational speed of 50 to 70 rpm under a pressure of 0.2 MPa.
Next, a two-stage defoaming process is performed. The defoaming step in the first stage is performed at a defoaming temperature of 105 ° C. and a defoaming pressure of −500 mmHg and a defoaming time of 30 minutes in terms of gauge pressure with the atmospheric pressure being 0 (zero). At this time, the first 10 minutes is rotated with a stirrer of 10 rpm, and then the deaeration is performed with the stirrer stopped. In the second defoaming step, the defoaming temperature is raised to 120 ° C., and the defoaming pressure is degassed in a gauge pressure notation of −500 mmHg with a defoaming time of 15 minutes.
The soft capsule shell solution obtained after defoaming was transferred to a small tank and stored at 75 ° C. for about 15 hours for use.
As the filling machine, a soft capsule manufacturing machine provided with a capsule skin sheet drying apparatus by infrared irradiation with medium wavelength, which is an apparatus developed by the present inventors, was used.
The obtained soft capsule skin solution was discharged from a spreader box and spread on cooling drums 22 on both sides of the filling machine 10 to form a sheet (outer sheet S). While drying the skin sheet S to a moisture content of 32% with a medium wavelength infrared heater, the skin sheet S is guided to the filling machine 10 and the contents (mixture of 70% by weight of MCT and 30% by weight of lecithin) are obtained. Immediately after filling, the soft capsule 1 was obtained by pressure bonding with a die (die roll 26).
<Filling conditions>
Casting drum temperature: 20 ° C
Medium wavelength infrared heater
(Manufactured by Heraeus Co., Ltd., model number: MBS1600 / 250): wavelength 2.6 μm
Segment temperature: 30 ° C
Die roll rotation speed: 3.0rpm
Filling room humidity: 24% RH
Filling chamber temperature: 26 ° C
 〔実施例1・実施例2・実施例3〕
 表1に示したように、金属塩としてクエン酸三ナトリウムを配合したカプセル外皮成分を加熱溶解釜に入れ0.2MPaの圧力下で、攪拌機の回転速度を50~70rpmで攪拌しながら、溶解温度110℃で80分間加熱溶解する。
 次に2段階からなる脱泡工程を行う。1段階目の脱泡工程は、脱泡温度105℃、脱泡圧力は大気圧を0(ゼロ)としたゲージ圧表記で-500mmHg、脱泡時間30分で行う。この時最初の10分は、攪拌機10rpmで回転させ、その後攪拌機を停止した状態で脱泡する。2段階目の脱泡工程は、脱泡温度120℃に上げ、脱泡圧力は大気圧を0(ゼロ)としたゲージ圧表記で-500mmHg、脱泡時間15分で脱泡する。
 脱泡後得られたソフトカプセル外皮溶液は、小分けタンクに移し、75℃で約15時間保管して用いた。
 充填機10としては、本発明者らが開発した装置である、中波長赤外線照射によるカプセル外皮シート乾燥装置を具えたソフトカプセル製造機を用いた。
 得られたソフトカプセル外皮溶液(外皮原料2A)を、充填機10の両側にある冷却ドラム22に展延することによりシート状(外皮シートS)にした。中波長赤外線ヒーター25により、外皮シートSの水分含量を32%になるよう乾燥しながら、その外皮シートSを充填機10に誘導して、内容物(MCT70重量%、レシチン30重量%の混合物)を充填した直後に、金型(ダイロール38)により圧着してソフトカプセル1を得た。
<充填条件>
キャスティングドラムの温度 :20℃
中波長赤外線ヒーター 
(ヘレウス株式会社製、型番:MBS1600/250):波長2.6μm
セグメント部温度:30℃
ダイロール回転数:3.0rpm
充填室湿度:24%RH
充填室温度:26℃
[Example 1 / Example 2 / Example 3]
As shown in Table 1, the capsule shell component containing trisodium citrate as a metal salt was placed in a heated dissolution kettle and stirred at a pressure of 0.2 MPa while stirring at a rotating speed of 50 to 70 rpm. Dissolve by heating at 110 ° C. for 80 minutes.
Next, a two-stage defoaming process is performed. The defoaming step in the first stage is performed at a defoaming temperature of 105 ° C. and a defoaming pressure of −500 mmHg and a defoaming time of 30 minutes in terms of gauge pressure with the atmospheric pressure being 0 (zero). At this time, the first 10 minutes is rotated with a stirrer of 10 rpm, and then the deaeration is performed with the stirrer stopped. In the second defoaming step, the defoaming temperature is raised to 120 ° C., and the defoaming pressure is degassed in a gauge pressure notation of −500 mmHg with a defoaming time of 15 minutes.
The soft capsule shell solution obtained after defoaming was transferred to a small tank and stored at 75 ° C. for about 15 hours for use.
As the filling machine 10, a soft capsule manufacturing machine provided with a capsule skin sheet drying apparatus using medium wavelength infrared irradiation, which is an apparatus developed by the present inventors, was used.
The obtained soft capsule outer skin solution (outer raw material 2A) was spread on the cooling drums 22 on both sides of the filling machine 10 to form a sheet (outer sheet S). While drying the skin sheet S to 32% by the medium wavelength infrared heater 25, the skin sheet S is guided to the filling machine 10 and the contents (mixture of 70% by weight of MCT and 30% by weight of lecithin). Immediately after filling, a soft capsule 1 was obtained by pressure bonding with a mold (die roll 38).
<Filling conditions>
Casting drum temperature: 20 ° C
Medium wavelength infrared heater
(Manufactured by Heraeus Co., Ltd., model number: MBS1600 / 250): wavelength 2.6 μm
Segment temperature: 30 ° C
Die roll rotation speed: 3.0rpm
Filling room humidity: 24% RH
Filling chamber temperature: 26 ° C
Figure JPOXMLDOC01-appb-T000001
Figure JPOXMLDOC01-appb-T000001
〔比較例1・比較例2・比較例3 評価結果〕
 比較例1で示したように、従来のロータリーダイ式自動ソフトカプセル製造機(ダイロール回転数:1.5rpm)で、カプセル外皮溶液の水配合量が80重量部だと、カプセル外皮溶液中に溶け込んだエアが抜けにくく、カプセル泡不良率が上昇した。
 一方、比較例2で示したように、従来のロータリーダイ式自動ソフトカプセル製造機(ダイロール回転数:1.5rpm)で、カプセル外皮溶液の水配合量を150重量部にすると、比較例1より脱泡性が改善され泡不良率は低いが、カプセルの接着性が悪く、カプセル内容物(MCT70重量%、レシチン30重量%の混合物)が液漏れするカプセルがあった。
 比較例3で示したように、比較例2と同じカプセル外皮原料の水配合量が150重量部で従来のロータリーダイ式自動ソフトカプセル製造機で、ダイロール回転数を1.5rpmから3.0rpmに上げると、カプセル接着面が十分に接着せず、カプセル形成直後からカプセル内容物(MCT70重量%、レシチン30重量%の混合物)が液漏れしており、液漏れ率が高かった。
[Comparative Example 1, Comparative Example 2, Comparative Example 3 Evaluation Results]
As shown in Comparative Example 1, when the water content of the capsule shell solution was 80 parts by weight with a conventional rotary die type automatic soft capsule manufacturing machine (die roll rotation speed: 1.5 rpm), it was dissolved in the capsule shell solution. It was difficult for air to escape and the capsule foam defect rate increased.
On the other hand, as shown in Comparative Example 2, when the amount of water in the capsule shell solution was 150 parts by weight with a conventional rotary die type automatic soft capsule manufacturing machine (die roll rotation speed: 1.5 rpm), it was removed from Comparative Example 1. Although the foamability was improved and the foam defect rate was low, there was a capsule in which the capsule adhesiveness was poor and the capsule contents (mixture of 70% by weight of MCT and 30% by weight of lecithin) leaked.
As shown in Comparative Example 3, the same amount of water as the capsule shell raw material as in Comparative Example 2 is 150 parts by weight, and the rotational speed of the die roll is increased from 1.5 rpm to 3.0 rpm with a conventional rotary die type automatic soft capsule manufacturing machine. The capsule adhesion surface did not adhere sufficiently, and the capsule contents (mixture of 70% by weight of MCT and 30% by weight of lecithin) leaked immediately after the capsule formation, and the liquid leakage rate was high.
〔比較例4 評価結果〕 
 クエン酸三ナトリウムは配合せず、リン酸二水素ナトリウムと塩化カリウムを配合した比較例4では、本発明者らが開発した装置である、中波長赤外線照射によるカプセル外皮シート乾燥装置を具えたソフトカプセル製造装置を使用すると、比較例1、2、3に比べ、ダイロール回転数を1.5→3.0rpmの2倍にしても、泡不良率が低く、接着が非常に良好で液漏れしないソフトカプセルが製造可能となった。
 しかしカプセル形成後の経時的な硬度低下が起きており、硬度安定性の問題は未解決のままであった。
[Comparative Example 4 Evaluation Results]
In Comparative Example 4 in which trisodium citrate was not blended but sodium dihydrogen phosphate and potassium chloride were blended, a soft capsule provided with a capsule skin sheet drying device by mid-wavelength infrared irradiation, which was developed by the present inventors When using the manufacturing equipment, compared with Comparative Examples 1, 2, and 3, even if the die roll speed is doubled from 1.5 to 3.0 rpm, the bubble defect rate is low, the adhesion is very good, and the liquid capsule does not leak Can be manufactured.
However, a decrease in hardness over time after capsule formation has occurred, and the problem of hardness stability remains unsolved.
〔実施例1・実施例2・実施例3 評価結果〕
 クエン酸三ナトリウムを配合した実施例1、実施例2、実施例3では、本発明者らが開発した装置である、中波長赤外線照射によるカプセル外皮シート乾燥装置を具えたソフトカプセル製造装置を使用すると、比較例1、2、3に比べ、ダイロール回転数を1.5→3.0rpmの2倍にしても、泡不良率が低く、接着が非常に良好で液漏れしないソフトカプセルが製造可能となった。
 さらに比較例4のように本発明者らが開発した装置である、中波長赤外線照射によるカプセル外皮シート乾燥装置を具えたソフトカプセル製造装置を使用しても問題になっていた、カプセル形成後の経時的な硬度低下が、実施例1、2、3では起きておらず、硬度安定性も向上させることができていた。
[Evaluation results of Example 1, Example 2, Example 3]
In Example 1, Example 2, and Example 3 in which trisodium citrate was blended, when a soft capsule manufacturing apparatus provided with a capsule skin sheet drying apparatus by mid-wavelength infrared irradiation, which was developed by the present inventors, was used. Compared with Comparative Examples 1, 2, and 3, even when the die roll speed is doubled from 1.5 to 3.0 rpm, a soft capsule that has a low bubble defect rate, very good adhesion, and does not leak can be manufactured. It was.
Further, even after using a soft capsule manufacturing apparatus equipped with a capsule skin sheet drying apparatus using medium wavelength infrared irradiation, which was an apparatus developed by the present inventors as in Comparative Example 4, time elapsed after capsule formation. No decrease in hardness occurred in Examples 1, 2, and 3, and the hardness stability could be improved.
 ここで、ソフトカプセル1を製造するにあたり、外皮原料2Aとして澱粉を主成分とした場合の困難性(ゼラチンを主成分とした場合に比べての困難性)について説明する。澱粉を主成分とした場合には、上述したように充填機10の乾燥能力を向上させる必要があるが、そのために例えば単に乾燥用の移送路24を長く形成し、長時間の乾燥を行うようにしただけでは不充分である。それは、乾燥には熱による変形が伴い、とりわけ移送路24を長く形成した場合には、その分だけ(長く形成すればするほど)、外皮シートSには、移送のため加わるテンション(引っ張り力)が大きくなり、完成状態のソフトカプセル1も変形し易いためである。具体的には、ダイロール38の成形凹部39の大きさが完成状態のソフトカプセル1とほぼ同じと考えられるが、(ゼラチンを主成分とした場合には、完成状態のソフトカプセル1は、成形凹部39とほぼ同じ大きさに形成される)、澱粉を主成分とした場合のソフトカプセル1では、成形凹部39の実寸よりもダイロール38の回転方向(外皮シートSの送り方向)に大きく縮み(例えば図5の拡大図の二点鎖線で示すように10~30%程度縮む)、ゼラチンを主成分とした場合に比べ、はるかに製造が困難となる。 Here, in producing the soft capsule 1, the difficulty when the starch is the main ingredient as the outer skin raw material 2A (difficulty compared with the case where the gelatin is the main ingredient) will be described. When starch is the main component, it is necessary to improve the drying capacity of the filling machine 10 as described above. For this purpose, for example, a long transfer path 24 is simply formed to dry for a long time. It is not enough to just do it. The drying is accompanied by deformation due to heat, and in particular, when the transfer path 24 is formed longer, the corresponding amount (the longer it is formed), the tension (pulling force) applied to the outer sheet S for transfer. This is because the soft capsule 1 in a completed state is easily deformed. Specifically, it is considered that the size of the molding recess 39 of the die roll 38 is substantially the same as that of the completed soft capsule 1, but (when gelatin is the main component, the completed soft capsule 1 is In the soft capsule 1 in which starch is the main component, the soft capsule 1 is formed in substantially the same size), and contracts more greatly in the rotational direction of the die roll 38 (feeding direction of the outer sheet S) than the actual size of the molding recess 39 (for example, FIG. As shown by the two-dot chain line in the enlarged view, it shrinks by about 10 to 30%), making it much more difficult to manufacture compared to the case where gelatin is the main component.
 本発明は、「医薬品」、「特定保健用食品」、「いわゆる健康食品」及び食品の分野のほか、内容物の選択により、例えば工業用調剤を内包したものなど工業の分野において利用することができる。 The present invention can be used in the fields of “pharmaceuticals”, “special health foods”, “so-called health foods” and foods, as well as in industrial fields such as those containing industrial preparations depending on the selection of contents. it can.
 1   ソフトカプセル
 2   外皮部
 2A  外皮原料
 10  ソフトカプセル製造装置(充填機)
 11  シート成形部
 12  カプセル成形部
 13  内容物供給部
 14  カプセル取出部
 15  乾燥装置
 15A 乾燥装置本体
 21  スプレダーボックス
 22  キャスティングドラム
 23  フィードロール
 24  移送路
 24A 移送路(オモテ面側)
 24B 移送路(ウラ面側)
 25  中波長赤外線ヒーター
 25A 中波長赤外線ヒーター(オモテ面側)
 25B 中波長赤外線ヒーター(ウラ面側)
 26  反射板
 26A 反射板(オモテ面側)
 26B 反射板(ウラ面側)
 27  支持体
 28  エア吹出体
 29  エア吸込体
 30  温度計
 31  カバー
 32  スリット
 33  蝶ボルト
 34  カバー
 37  フィードロール
 38  ダイロール
 39  成形凹部
 40  成形突起
 41  吸引孔
 44  セグメント
 45  原液ホッパ
 46  ポンプユニット
 47  デリバリーパイプ
 50  掻取ブラシ
 51  前送コンベヤ
 52  フリーローラ
 53  コンベヤ
 N   内容物
 P   ポケット部
 S   外皮シート
 S′  ブランクシート
DESCRIPTION OF SYMBOLS 1 Soft capsule 2 Outer part 2A Outer raw material 10 Soft capsule manufacturing apparatus (filling machine)
DESCRIPTION OF SYMBOLS 11 Sheet shaping | molding part 12 Capsule shaping | molding part 13 Content supply part 14 Capsule taking-out part 15 Drying apparatus 15A Drying apparatus main body 21 Spreader box 22 Casting drum 23 Feed roll 24 Transfer path 24A Transfer path (front side side)
24B Transfer path (back side)
25 Medium Wavelength Infrared Heater 25A Medium Wavelength Infrared Heater (Front Side)
25B Mid-wave infrared heater (back side)
26 Reflector 26A Reflector (front side)
26B Reflector (back side)
27 Support body 28 Air blowout body 29 Air suction body 30 Thermometer 31 Cover 32 Slit 33 Butterfly bolt 34 Cover 37 Feed roll 38 Die roll 39 Molding recess 40 Molding projection 41 Suction hole 44 Segment 45 Stock solution hopper 46 Pump unit 47 Delivery pipe 50 Scratch Take Brush 51 Forward Conveyor 52 Free Roller 53 Conveyor N Contents P Pocket Part S Outer Sheet S 'Blank Sheet

Claims (8)

  1.  一対のダイロール間に外皮シートを対向的に拝み合わせ状態に供給し、ダイロールの突合わせ作用によって外皮シートの接合を図るとともに、接合に合わせて内容物を外皮シートに供給し、外皮シートから成る外皮部の内側に内容物を収容したソフトカプセルを製造する方法において、
     前記外皮部は、原料の構成成分組成として澱粉、λカラギーナン、金属塩、可塑剤、及び水を配合して形成され、
     前記外皮部のλカラギーナンの配合量が、乾燥前の溶液段階で澱粉100重量部に対して5~25重量部であり、
     前記外皮部の金属塩の配合量が、乾燥前の溶液段階で澱粉100重量部に対して1~20重量部であり、
     前記外皮シートは、一対のダイロールによる接合を受けるまでの間に、中波長赤外線による乾燥を受け、これによりほぼ一定の厚さ、適度の粘性、水分含量を有するシート状に形成されることを特徴とするソフトカプセルの製造方法。
    The outer sheet is supplied in a face-to-face state between a pair of die rolls, and the outer sheet is joined by the butt action of the die rolls, and the contents are supplied to the outer sheet in accordance with the bonding. In a method of manufacturing a soft capsule containing contents inside a part,
    The outer skin part is formed by blending starch, λ carrageenan, metal salt, plasticizer, and water as a constituent component composition of raw materials,
    The amount of λ carrageenan in the outer skin part is 5 to 25 parts by weight with respect to 100 parts by weight of starch in the solution stage before drying,
    The amount of the metal salt in the outer skin part is 1 to 20 parts by weight with respect to 100 parts by weight of starch in the solution stage before drying,
    The skin sheet is dried by medium-wavelength infrared rays until it is joined by a pair of die rolls, thereby forming a sheet having a substantially constant thickness, moderate viscosity, and moisture content. A method for producing soft capsules.
  2.  前記金属塩がクエン酸三ナトリウムであり、
     前記外皮シートを乾燥させるために照射する中波長赤外線の波長は、0.8~4.0μmであることを特徴とする請求項1記載のソフトカプセルの製造方法。
    The metal salt is trisodium citrate;
    The method for producing a soft capsule according to claim 1, wherein the wavelength of the medium wavelength infrared ray irradiated for drying the outer skin sheet is 0.8 to 4.0 µm.
  3.  前記外皮シートは、中波長赤外線照射による乾燥によって、一対のダイロール間に送り込まれる段階での水分含量が、好ましくは30~40%、より好ましくは32~38%に乾燥されることを特徴とする請求項1または2記載のソフトカプセルの製造方法。 The skin sheet is preferably dried to a moisture content of 30 to 40%, more preferably 32 to 38% when it is fed between a pair of die rolls by drying by infrared irradiation with medium wavelength infrared rays. The manufacturing method of the soft capsule of Claim 1 or 2.
  4.  請求項1、2または3記載のソフトカプセルの製造方法によって、経時的な硬度低下を抑制したことを特徴とするソフトカプセルの製造方法。 A method for producing a soft capsule, characterized in that a decrease in hardness over time is suppressed by the method for producing a soft capsule according to claim 1, 2 or 3.
  5.  前記λカラギーナンに対する比率が、λカラギーナン:κカラギーナン:ιカラギーナン=1:0.1:0.1~1:4:4のκカラギーナンとιカラギーナンを更に含有することを特徴とする請求項1、2、3または4記載のソフトカプセルの製造方法。 The ratio to λ carrageenan further comprises κ carrageenan and ι carrageenan of λ carrageenan: κ carrageenan: ι carrageenan = 1: 0.1: 0.1 to 1: 4: 4, 2. A method for producing a soft capsule according to 2, 3 or 4.
  6.  前記金属塩が、クエン酸三ナトリウムの他、コハク酸ナトリウム、グルコン酸ナトリウム、リン酸水素二ナトリウム、リン酸二水素ナトリウム、塩化ナトリウム、塩化カリウム、塩化マグネシウム、塩化カルシウム、乳酸カルシウムからなる群から選ばれる1種類又は2種類以上の組み合わせであることを特徴とする請求項1、2、3、4または5記載のソフトカプセルの製造方法。 The metal salt is selected from the group consisting of trisodium citrate, sodium succinate, sodium gluconate, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride, potassium chloride, magnesium chloride, calcium chloride, calcium lactate. 6. The method for producing a soft capsule according to claim 1, 2, 3, 4 or 5, wherein the soft capsule is one kind or a combination of two or more kinds.
  7.  一対のダイロール間に外皮シートを対向的に拝み合わせ状態に供給し、ダイロールの突合わせ作用によって外皮シートの接合を図るとともに、接合に合わせて内容物を外皮シートに供給し、外皮シートから成る外皮部の内側に内容物を収容したソフトカプセルを製造する方法において、
     前記ダイロールの突合わせ作用によって外皮シートの接合を図る際に、外皮シートに熱をかけるためのセグメント部の温度が30~40℃であることを特徴とする請求項1、2、3、4、5または6記載のソフトカプセルの製造方法。
    The outer sheet is supplied in a face-to-face state between a pair of die rolls, and the outer sheet is joined by the butt action of the die rolls, and the contents are supplied to the outer sheet in accordance with the bonding. In a method of manufacturing a soft capsule containing contents inside a part,
    The temperature of the segment part for applying heat to the outer sheet when the outer sheet is joined by the butt action of the die roll is 30 to 40 ° C, A method for producing a soft capsule according to 5 or 6.
  8.  請求項1、2、3、4、5、6または7記載のソフトカプセルの製造方法によって製造されたソフトカプセル。 Soft capsules produced by the method for producing soft capsules according to claim 1, 2, 3, 4, 5, 6 or 7.
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JP2017186282A (en) * 2016-04-07 2017-10-12 アリメント工業株式会社 Rotary die type minimal soft capsule
JP2021020274A (en) * 2019-07-26 2021-02-18 株式会社ディスコ Waste liquid disposal device

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JP2008237572A (en) * 2007-03-27 2008-10-09 Sankyo:Kk Soft capsule skin derived from non-animal material and soft capsule having the same
WO2010035327A1 (en) * 2008-09-26 2010-04-01 株式会社三協 Process for producing soft capsule and apparatus for producing the same

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JP2008237572A (en) * 2007-03-27 2008-10-09 Sankyo:Kk Soft capsule skin derived from non-animal material and soft capsule having the same
WO2010035327A1 (en) * 2008-09-26 2010-04-01 株式会社三協 Process for producing soft capsule and apparatus for producing the same

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Publication number Priority date Publication date Assignee Title
JP2017186282A (en) * 2016-04-07 2017-10-12 アリメント工業株式会社 Rotary die type minimal soft capsule
JP2021020274A (en) * 2019-07-26 2021-02-18 株式会社ディスコ Waste liquid disposal device
JP7339049B2 (en) 2019-07-26 2023-09-05 株式会社ディスコ Waste liquid treatment equipment

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